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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 9500-45
Device Problem Appropriate Term/Code Not Available
Event Date 06/25/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that a replace sensor now message occurred. It was indicated that a patient under 2 years of age was using our device which is off label usage of the device. It was also indicated that an alternate site insertion occurred which is off label usage of the device. Data was evaluated and the allegation was confirmed as a early sensor expiration was confirmed. The probable cause was determined to be early sensor expiration. The probable cause of the early sensor expiration could not be determined. The reported event of a replace sensor now message is reportable based on the finding of an early sensor expiration. 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 Key9772643
Report Number3004753838-2020-020215
Device Sequence Number1
Product CodeQBJ
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 02/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number9500-45
Device Catalogue NumberSTS-OR-001
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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