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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 MT22719-BLU
Device Problem Failure to Charge (1085)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The g5 system is associated with product code pqf.
 
Event Description
Dexcom was made aware on (b)(6) 2016 that on (b)(6) 2016, that the receiver would not hold a charge. No additional event or patient information is available. The complaint device was returned for evaluation. The device was visually inspected and no defect was found. Functional testing was performed and the test failed. The receiver log was reviewed and screen error alarms and firmware errors were observed. The customer complaint was confirmed. A root cause was determined to be a ui-u1 related failure. Based on the findings of receiver would not hold a charge, this issue has been upgraded from non-reportable to reportable.
 
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Brand NameDEXCOM G5 MOBILE 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
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key6385393
MDR Text Key69293121
Report Number3004753838-2017-17595
Device Sequence Number1
Product Code MDS
UDI-Device Identifier20386270000273
UDI-Public(01)20386270000273(241)STR-GF-BLU(10)5220381
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 12/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22719-BLU
Device Catalogue NumberSTR-GF-BLU
Device Lot Number5220381
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2016
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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