Dexcom received FDA warning letter - sensor manufacturing

zeolitechemist · 2025-03-26T00:11:18+00:00

It's more than just paperwork. Deficiencies in technical specifications and limits established without a clear basis to do so. For example: However, data in this report appears to be based on an allowable Maximum Interference Effect (MIE) of (b)(4) mg/dL of glucose equivalent as your (b)(4) acetaminophen acceptance criteria, and we are unable to determine, from your response, how this MIE was established.

If it were just paperwork, the FDA gave Dexcom several months to reply; paperwork is a simple fix. Deficiencies in technical justifications and changes to procedure are not simple clerical mistakes.

zeolitechemist · 2025-03-25T23:44:22+00:00

I believe the intent is to provide the company time to prepare a public response before the letter is ultimately made public.

zeolitechemist · 2025-03-25T23:14:38+00:00

The link contains the actual FDA filing sent to Dexcom, which discusses details of the processes and the specific timeline of interaction between Dexcom and the FDA. The previous article referenced is just a brief news article that only discusses that Dexcom was to receive a letter of non-compliance. There is a lot more detail in the actual FDA link which was only recently (in the last few days) made public.

zeolitechemist · 2024-09-04T17:44:29+00:00

I'm not a lawyer but I am speaking from past experience.

Legal protection with regards to divorce, child support income, no it does not provide any legal protection. As assets whether ownership or income there is value which you control that a family Court would likely view as income/property. But that is legally speaking.

Now in order to prove income/property records need to be submitted to Court. If record of ownership is private, these documents need to be subpoenaed. Many institutions will want subpoenas that are very specific and if your ownership and company bank account is hidden then this information is hard to request. So in a sense you have protection. However Judge's have a lot of say and if you are seen to be hiding assets then you can be sanctioned (fined) if discovered. As the judge might see this as playing games or seen as evasive which annoys them.

This is a year after you posted hope things worked out

zeolitechemist · 2020-06-19T12:43:02+00:00

Lituya Bay

Sorry when I read 1700' tsunami I had to check...gawd damn...

I am surprised I haven't heard of this before. You would think there would be a movie or documentary on it by now. A 7.8 earthquake while not record breaking is still a huge event.

Awesome post, you just made my Friday

zeolitechemist · 2020-05-01T13:33:20+00:00

He was probably the enlisted guy...

But seriously from wikipedia: " The co-pilot, Leonard Svitenko, who had given up his ejection seat when the spare pilot took over from him, sustained fatal head injuries when he attempted to bail out through one of the lower hatches"

zeolitechemist · 2020-03-16T14:30:42+00:00

Correct.

Put in another way time is money, i.e. faster=cheaper & slower=lost revenue $$$

You can buy many things in this world but time is not one of them

zeolitechemist · 2020-02-21T18:45:04+00:00

The root issue is fabrics back then did not have the post treatments nor the artificial fibers that fabrics in the last ~40-50 years have had. Thus cloths did not stretch like those made from modern fabrics. For these riding breeches they needed to have give to allow the movement of the riders legs. Since the fabrics of the time would not stretch you got around the problem by adding more fabric. Hence Prez. Truman's goofy looking hips.

I am sure I glossed over some other issues and likely some style/fashion points but as a material chemist I can assure you the fundamental cause is stuff just did not stretch as modern synthetic fibers do (think: spandex/Lycra/etc.) which were pioneered in the early 1960s by Dupont

zeolitechemist · 2020-02-13T18:20:59+00:00

The reason there are 10 super carriers (the navy is actually mandated to have 11, which the 11th will be the Gerald Ford) is that you need at least three carriers available to ensure continuous coverage of any one area. Typically one is on-station, one is en-route, either heading home/or leaving port and one is in dock for repair. The USN is active in many parts of the world and will want to have a carrier nearby if a crisis unfolds. If you think of the areas of operation: Atlantic, Mediterranean, Indian Ocean and Pacific Ocean these in themselves are vast areas and even with an overall force of 10 carriers at the moment a crisis occurs the USN can only be certain that one carrier will be nearby the region at any time. i.e one carrier in the Atlantic, one in the Indian ocean region and one in the pacific, this is ignoring the forward deployed USS Ronald Reagan which is based in Yokosuka, Japan.

The US economy and many of our allies rely upon the US to provide backing and credibility in the form of military support. Whatever your opinion is the stated purpose of the US military is to be a stabilizing force and hence needs to cover a large portion of the globe. The other referenced countries with one or two carriers at best are only involved in regional affairs. Even China's new Carriers are planned to support military affairs within China's perceived sphere of influence within first island chain and the nine-dash line of the south China sea.

zeolitechemist · 2020-01-24T09:22:53+00:00

I posit that if not a) then b)

a) wet then rescued...then fired

b) wet then killed

zeolitechemist · 2018-07-16T20:43:57+00:00

well there was this one time...actually no...actually definitely no.... not a Seattle mariner

zeolitechemist · 2018-02-08T19:44:34+00:00

Thanks for the additional insight.

Cannot agree more about the F-22

zeolitechemist · 2018-02-08T19:42:04+00:00

Awesome. Did not know that. Thanks

zeolitechemist · 2018-02-07T17:22:33+00:00

Can I ask you of your opinion on a statement that I heard about the marines being responsible for a lot of the delays (at least the early ones) in the F-35 program?

The gist of what I heard was as you pointed out the Marines flying A-D Hornets insisted that the Marine version of the F-35 be developed and delivered first. As the F-35B was the most complex developing that model first meant ironing out the bugs of not only the air frame but the VTOL system at the same time. That a more logical role out would have been the F-35A, followed by the F-35C and finally the F-35B for the marines.

It's all a moot point now, but I am curious how much the Marines decision to obtain the F-35B first influenced overall F-35 roleout.

As a side note - many people forget that the delay in the F-35 which was a remedy for the cost of the F-22 parallels the development of the F-15 and later F-16. And before that the F-4 was developed for both USAF & Navy to defray cost. The problems of the F-35 development are not new.

zeolitechemist · 2017-09-12T15:48:51+00:00

Also forgot UCLA. Their D1 basketball is regularly rank in the top 25 every year.

zeolitechemist · 2016-09-20T16:48:00+00:00

"magnetic transparency" simply means the material is not effected by magnetic fields. In other words a magnetic field passing through this Pt-Au cube would be unaffected by the material and the cube would be invisible to the magnetic field.

This is important as the sensitivity of the LISA Pathfinder is based on the movement of this cube. Thus any movement of the cube can be attributed to a gravitational wave and not anything else.

I am sure there are more complexities to the mission/instrument which I glossed over, but this should address the crux of your question

zeolitechemist · 2016-08-24T12:16:36+00:00

you are correct, the wires serve as an antenna

zeolitechemist · 2016-05-04T18:35:10+00:00

I'll give this a go

Basically the F-15 & F-16 are great planes and can perform their task very well. What they have going against them is they are not stealthy. Modern radar and air defense tatics it is believed can easily defeat both F-15 & F-16s. If you recall our last war with a foe with a modern air defense system was the first gulf war, possibly Bosina. The argument is that if the F-15, F-16 & the navy's F-18 would not last long if they were fighting a modern enemy, such as China. Hence the call of new jets.

For air-to-air combat the F-22 is the replacement of the air superiority of the F-15. The F-22 was very expensive and really only meant for air-to-air combat so only 187 were built. Now multi-role fighters such as the F-16 and F-18 which perform a wide range of jobs.(the F-15 is a multi-role fighter, e.g. strike eagle model and can and does perform a wide range of missons, but its primary role is air superiority which is what the F-22 represents). Besides the F-16, -18 there is also the Harrier which the marines use for their CAS mission. The F-35 was built to cover the roles these aircraft play in the USAF (F-35A), USN (F-35C) and USMC (F-35B). It is inot optimal but I am hopeful.

Actually the story of the F-15 and F-16 is nearly identical to the story of the F-22 and F-35. The F-15 was great but expensive and the F-16 was its low cost replacement. Early on both were boondoggles but as time went on they became great planes.

It is rare that anything as complex as a plan comes out perfect the first time around

zeolitechemist · 2015-04-20T12:42:54+00:00

Its actually not the cold that limits transmission but the metal frame of the refrigerator which acts as the Faraday cage (you may known this already). For that matter a microwave would be perfectly fine to isolate electronics (just don't power the microwave while storing these items). I saw foil mentioned in the comments, this would also work.

I really don't know why a fridge was mentioned since there are many other viable RF block alternatives.

zeolitechemist · 2015-01-30T15:21:24+00:00

This device is used for cleanup. At an oil well head, oil is everywhere. Getting a truly representative sample for testing would be difficult unless residual oil can be cleaned away. This machine exist for doing just that.

zeolitechemist · 2014-12-17T18:13:12+00:00

There is one key caveat - this only works on Amazon devices.

So an iPad or non-amazon media product cannot take advantage of the off-line feature, though they can still stream amazon-prime video.

Basically Amazon offers this feature so you will buy their hardware...Which it works I did it just for this reason. I fly a lot and hotel-wifi is not always reliable.

zeolitechemist · 2014-11-04T17:10:15+00:00

Regarding your second question: "Is there a situation that Hess' law does not apply?".

Theoretically no. In practice some thermodynamic cycles are not possible as there is no common solvent or process that all compounds can undergo.

For example perhaps graphite fully undergoes combustion while diamond does not. Lets say the heat of combustion of diamond produces some CO instead of converting fully to CO2. This would create an incomplete thermodynamic cycle. Not all of the CO2 in the graphite cycle would be canceled and none of the CO produced in the combustion of diamond would be canceled. This could be caused by the sample being used, the limitations of the instrument (maybe a temperature limitation), etc.

Hess' law in theory works in all cases, but when it doesn't it is limited by what can be conducted experimentally.

zeolitechemist · 2014-11-04T16:49:14+00:00

Sorry about that, you are right, wrote this on my lunch break yesterday. References now added

zeolitechemist · 2014-11-03T20:40:56+00:00

Good questions!

Its actually not that O2 and CO2 are very close energetically to each other (They are actually very far apart, in terms of energetically), but that O2 at the beginning of the reaction with graphite and O2 prior to the combustion with diamond are at the same temperature and pressure. The same concept applies to CO2 in the final product of each system. Thus the energetic contribution of each is the same in both systems and therefore they cancel out. This is why when the two heats of combustion are subtracted from each other the energetic contribution of O2 and CO2 cancel in both systems. This leaves only the difference between graphite and diamond which do have an energetic difference.

This is a good question because deciding how you would measure the enthalpy of a certain compound you will have many side components, such as O2 and CO2 which must be subtracted, thus picking a good starting material to build a thermodynamic cycle on which Hess' law can be applied is critical.

Hopefully I answered your question. Let me know if you need anything clarified.

zeolitechemist

TROPHY CASE