A message from Ardens Mom

DexCom recently received a warning letter from the FDA that got a lot of attention in the diabetes world.  The following is a message from my wife, (and Arden’s mom) Kelly.  Kelly happens to have some expertise in these matters and she wanted to share her thoughts on the letter and what it means.

“RE: FDA Warning Letter to Dexcom 

Hello.  I am Arden's mom.  I have been a Drug Safety Professional for 14+ years. In addition to my BS and MS, I have a Certification in Medical Devices.  I read Dexcom's Warning Letter with my "Mommy" and my "Drug/Device Safety" hat on and I thought I'd add a little perspective here. 

Drug/Device Safety Professional: 

While a Warning Letter from an FDA inspection is never a good thing for any company, they happen more frequently than you'd expect. FDA is tasked with ensuring public safety by ensuring companies have adequate Quality Management Systems in place (this includes Medical Device Reporting of adverse events).  What jumped out at me while reading this Warning Letter, was that for over 2 years, Dexcom had not been forwarding reports of wire fractures to FDA.  How in the world was that missed?? 

The CFR (Code of Federal Regulations - the law that is followed by drug and medical device manufacturers) says that a manufacturer (like Dexcom) has 30 calendar days to forward information to the FDA if the information reasonably suggests that the device may have caused or contributed to a death or serious injury; or if the device has malfunctioned, and if the device were to malfunction in the same way....it would likely cause or contribute to a death or serious injury. So...we know what "death" is, but what is considered to be a "serious injury"?  According to FDA, serious injuries include: life threatening injuries, permanent impairment of a body function or permanent damage to a body structure, or something that requires medical or surgical intervention to prevent permanent impariment of a body function or permanent damage to a body structure. Does our example of a fractured wire qualify as a malfunction that could lead to serious injury if it happens again?  The answer is YES!   

Customer Report 09-5141 in the Warning Letter details a 3-year-old having surgery under general anesthesia to remove the fractured wire.  RED FLAG! - If a Health Care Professional felt that a wire left in the skin of a small child required surgical intervention to remove, that is significant and easily meets FDAs definition of a "reportable MDR"; that is, a malfunction occurred (the fractured wire was left in the skin) and surgical intervention was required to prevent serious injury.  It doesn't get any clearer than this....why wasn't Dexcom forwarding these reports to FDA as they should have been....for over 2 years??  For me, this calls into question Dexcom's Medical Device Reporting System.  I assume Dexcom is working diligently right now on training their staff since this most basic concept was not understood by Dexcom's Safety Team.  It is not uncommon for FDA inspections to spur companies into investing the time and resources needed to create a robust, efficient and compliant Safety Group. 

Mommy: 

Oh no!  My little girl is wearing this thing!!!  Deep breaths....... 

Drug/Device Safety Professional & Mommy: 

Dexcom has some work to do - let's hope they do it because my little girl (a physically tiny 5-year-old) needs their product.  Working in the drug/device world is tough. I sympathize with Dexcom, like managing a child with Type 1, Device Safety can be more of an art than a science. All things considered, the incidence of this happening is relatively low (3 per 10,000 distributed devices) - no device is perfect.  When I think of the options -- use the device with a small possibility of a fractured wire vs not using the device and risking terrible lows and seizures.....I'll use the device and be really careful inserting and removing it!  As parents, we need to weight the benefits and the risks.  The risk of a serious injury is relatively low.....I drive on 287 in NJ everyday...and THAT is risky, but I do it. I am not overly concerned about the Warning Letter. Dexcom has a good product and it's in their best interest to put Corrective Actions and Preventive Actions in place to correct their errors on Medical Device Reporting.  At least it's on everyone's radar now!  And as they say, knowledge is power....and we need that power because to our kids we are SuperHeros!”

You can follow Kelly on Twitter @KellyABenner