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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9445-02
Device Problem Imprecision
Event Date 01/14/2020
Event Type  Malfunction  
Manufacturer Narrative

No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that there was an inaccuracy between the continuous glucose monitor (cgm) reading and the blood glucose (bg) meter reading. Reportedly, the cgm bg reading was 101 mg/dl, and the meter bg reading was 394 mg/dl. No additional patient or event information was available. A root cause could not be determined. A replacement sensor was sent to the customer.

 
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Brand NameDEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
mick trier
san diego , CA 92121
8584011451
MDR Report Key9656090
Report Number3013756811-2020-10927
Device Sequence Number1
Product CodeQBJ
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 01/31/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/31/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number9445-02
Device Catalogue NumberSTS-OR-001
Device LOT Number5263602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received01/15/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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