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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSOR; SENSOR, GLUCOSE, INVASIVE
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DEXCOM, INC. DEXCOM G6 SENSOR; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number
Device Problems Communication or Transmission Problem (2896); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 06/02/2021
Event Type  Injury  
Event Description
I am a type 1 diabetic, (b)(6) years old, 52 years as a diabetic.I am a tandem pump user and a dexcom cgm user.With both devices linked electronically.For the past 7 days, i have had problems with the dexcom sensor device and the transmitter.Both the transmitter and the sensor failed --- one invalid transmitter device error, one invalid data error and two sensor errors.This is not the first time this has happened.I've been a dexcom and tandem pump user for the past 10 years, and over the past 18 months, these two device failures have occurred multiple times.Each time they happen, i am forced to monitor my blood sugar proactively / intermittently, unlike having the benefit of 24/7 blood sugar readings with the pump / sensor / transmitter devices linked.The 6.1 a1c result is actually a very good result in terms of a1c.The problems with the device(s) have occurred since then, and have raised my a1c considerably.Fda safety report id # (b)(4).
 
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Brand Name
DEXCOM G6 SENSOR
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11946362
MDR Text Key254842678
Report NumberMW5101721
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/02/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot Number
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Age68 YR
Patient Weight91
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