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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
Model Number PN 9500-45
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Markings/Labelling Problem (2911); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 11/02/2021
Event Type  Injury  
Event Description
Insulin pump malfunction. Dexcom g6 sensor - outside box lot - 7295419, expiration - 2022-01-31. Actual sensor outer sterile paper marked with lot - 7277640 and exp 2021-07-25. Did not notice the discrepancy when sensor activated at 0802 hours this date. Sensor inaccurately reporting blood glucometer, shutting off insulin delivery. Sensor failed three times since 1400 hours edt this date, for greater than 1 hour at a time. Called tandem. Replacing sensor. Dexcom called. Replacing sensor. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM , INC
MDR Report Key12771153
Report NumberMW5105157
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000255
UDI-Public0100386270000255
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2022
Device Model NumberPN 9500-45
Device Lot Number7277640 ON LABEL;7295419 ONBOX
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Patient SexMale
Patient Weight79 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
Patient Treatment(s)
B2; MVI; ZINC; CRESTOR; ESSENTIAL OILS; FISH OIL; LISINOPRIL; MELATONIN; SYNTHROID; VERAPAMIL; VIT C; VIT D3
Patient Outcome(s) Other;
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