MAUDE Adverse Event Report: DEXCOM DEXCOM 5; CONTINUOUS GLUCOSE MONITOR

Model Number DEXCOM 5

Device Problems Defective Component (2292); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2018

Event Type  Injury  

Event Description

I use a "dexcom 5" blood glucose monitoring unit, as i have insulin dependent diabetes (it is my understanding that the dexcom unit is under the authority" / "purview" of the fda, hence this correspondence to you).The discrepancy between readings from my dexcom unit and my blood glucose meter is typically at least 20-25% (both "directions" i.E.Sometimes my unit has a lower number than my meter, and viceversa).On (b)(6) 2018, that discrepancy was in excess of 100%, which does not allow me to effectively use the dexcom unit to help monitor/assist with the control of my diabetes, in contravention of the reason for the unit's existence/availability on the market for consumers.I have 3 issues relative to the above, and i thank you in advance for considering them, in your determination whether to proceed with contacting dexcom: i am not sure if my unit is defective, and whether any potential "defect' relates solely to its interaction with my body, or whether any potential "defect" is more "widespread"; relative to item 1, i attempted to contact dexcom's "tech support" via phone calls, on (b)(6) 2018.Specifically, that the last thursday, i attempted to call the 3 tech support phone lines that dexcom offers, during a 3 hour period.I made no less than 8 calls.I was placed on "hold", every time i called, so this inability to contact them for assistance was not related to a problem with my phone.My inability to contact a live person made it impossible to determine if there was a "defect" with my unit, or whether there was simply an "addressable" issue, for correction.Since i was unable to reach tech support via phone, i did exactly what i have had to do, numerous times, in the past (because of my difficulty in reaching them by phone): i sent an email to "techsupport@dexcom.Com" on friday, outlining my issue.I have yet to receive a response from them.I will be glad to forward that email to you.If you wish to view it; in dexcom's literature, they tout available tech support assistance, "24/7".Since i have extreme difficulty reaching them, either by phone, or email, i voice my concern that they are not providing the available assistance that they strongly assert.To summarize, i am not sure if i have a problem with my unit that merits your investigation, but, at the least, i feel the above merits your investigation.Specifically, i assert that dexcom's tech support system is woefully understaffed, in light of the ongoing history of my inability to reach them via one of their phone lines.If dexcom is "pushing" this "assistance is available 24/7", and they are not providing same, that is an injustice to their customers.Customers expectations cannot be met, if their lines are understaffed.Relatedly, if they are not in position to offer the touted "we are here for you 24/7" assurance.I request that the fda consider having them add info to their literature that "delays might occur." if i had seen such a "disclaimer", then my justifiable expectation of assistance would be "tempered".Dexcom has not met my expectations, and that adds to my anxiety/confidence in the product, as well as confidence in their available support (of the few times i have reached someone, they have been most competent, so this is an issue of understaffing, not a concern about the competence of their staff).Thanks for the time afforded me.

• Brand Name: DEXCOM 5
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM
• MDR Report Key: 7334157
• MDR Text Key: 102332406
• Report Number: MW5075812
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/24/2018
• Device Model Number: DEXCOM 5
• Device Lot Number: 6004439
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 64 YR
• Patient Weight: 93