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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 Premature End-of-Life Indicator (1480)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that low transmitter battery alert occurred on for transmitter (b)(4). However, transmitter (b)(4) was returned for evaluation. The product was evaluated. An external visual inspection was performed and passed. Transmitter voltage test was performed and failed due to 0 voltage. A review of the share logs was performed and insert issue was not found within the investigation window. The allegation was not confirmed. The probable cause could not be determined. However, a failed transmitter error was found in connection to the reported allegation. The reported issue of a low transmitter battery alert is reportable based on the finding of a failed transmitter error. No injury or medical intervention was reported.

 
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Brand NameDEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
ashley spoto
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key10475104
MDR Text Key205085249
Report Number3004753838-2020-097221
Device Sequence Number1
Product Code QBJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberDEN170088
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/31/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2020
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 NumberSTT-OE-002
Device LOT Number5273506
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/05/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/20/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/25/2020
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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