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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9438-06
Device Problem No Device Output (1435)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/11/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that transmitter failed error occurred. No product or data was provided for evaluation. Confirmation of the allegation and a probable cause could not be determined. No injury or medical intervention was reported.

 
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Brand NameDEXCOM G5 MOBILE 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 Key10475099
MDR Text Key205088374
Report Number3004753838-2020-097087
Device Sequence Number1
Product Code PQF
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberP120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
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 Number9438-06
Device Catalogue NumberSTT-GF-004
Device LOT Number5271860
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 Received08/13/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/28/2020
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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