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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT20649-1
Device Problem Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the patient reported that liquid from the receiver battery had leaked. No additional patient or event information is available. No product was provided for evaluation. The complaint confirmation could not be determined. A root cause could not be determined.
 
Manufacturer Narrative
Sr-(b)(4).
 
Event Description
It was reported that liquid from the receiver battery had leaked. The product was evaluated. The device was externally visually inspected and passed. The receiver failed to charge and reboot due to the receiver not booting up or communicating. Functional testing failed due to the receiver not booting up or communicating. The log was unable to be downloaded due to the receiver not booting up or communicating. The receiver case was opened, the internal inspection failed due to moisture damage on the main circuit board. Confirmation of the allegation and a root cause could not be determined. No injury or medical intervention was reported.
 
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Brand NameDEXCOM G4 PLATINUM 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
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key8169606
MDR Text Key130509459
Report Number3004753838-2018-157593
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-1
Device Catalogue NumberSTK-GL-010
Device Lot Number5223611
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2017
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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