MAUDE Adverse Event Report: DEXCOM, INC. SENSORS; SENSOR, GLUCOSE, INVASIVE

Model Number G6

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Hyperglycemia (1905)

Event Date 08/04/2021

Event Type  malfunction  

Event Description

Very high blood sugar; i'm reporting a dexcom g6 failure.I use a dexcom g6 continuous glucose monitor due to t1 diabetes.The sensor was on a day 10 of a supposed 10-day period, but still at least 11 hours from a due change out of sensor.Issue: the sensor failed to report my blood glucose accurately by over 100 points and i depended on the data to both administer insulin for a meal and correct for a low bg.This morning, i took insulin for a meal calculated at 55 carbs, determining 4 units of insulin were needed.The following occurred: 8:15 am: i injected 4 units of insulin; the g6 reported a bg of 131.8:33 am: i ate the meal; at the beginning of which the g6 reporting a bg of 120.8:53 am: the g6 alarmed, indicated a bg of 75 and dropping quickly (down arrow).I believed the insulin had taken effect earlier than normal and took 3 glucose tabs to prevent a severe low bg.9:03 am: the g6 indicated a rise to a bg of 89.I believe the glucose tabs had taken a slightly quicker effect than normal.9:19 am: the g6 alarmed again, indicating a drop of bg to 65 and dropping rapidly, within 2 minutes, it stopped working and indicated a communications error and i needed to wait up to 3 hours for reconnection.9:22 am: based on reports of this being a known failure type with dexcom g6, i tested with a contour next one bg meter by finger stick, and it reported a bg of 188; i immediately retested to confirm and it reported a bg of 187.9:38 am: the dexcom g6 resolved its communication issue and reported a bg of 156 and stayed from 156 to 150 for the next hour.The dexcom sensor or transmitter obviously had a fault for no apparent reason, no medicines had been taken, no odd sitting/standing positions, no impacts to the sensor/transmitter/receiver.I called the dexcom hotline and reported the issue and the person, obviously reading from a script said he'd report it and send a new sensor.The issue: dexcom has this or similar issues regularly, per reporting of many diabetics that use the products, yet dexcom, with fda approval, continues to market the device as accurate with no finger sticks required.The dexcom rep i spoke with indicated "well, it is the 10th day, it was due to be replaced" apparently thinking i'd accept that.Well, the device is supposed to be good for 10 days, not 9+ a little.I, and millions of others, depend on the company and the fda to assure us of accuracy and dependability.Improvement on the latter is needed, alternately, dexcom and the fda need to reduce the time period the device is dependable for, otherwise, use of the device needs to be accompanied by a warning to verify lows or highs, or whatever the reading is, with a separate meter.Which makes the device useless.Fda safety report id# (b)(4).

• Brand Name: SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12287677
• MDR Text Key: 265644193
• Report Number: MW5103054
• Device Sequence Number: 2
• Product Code: MDS
• 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: 08/04/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G6
• Device Catalogue Number: 9500-45
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 65