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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G4 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR: Back to Search Results
Model Number MT20649-2
Device Problem Failure to Charge (1085)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/25/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, the patient experienced receiver does not hold charge. No additional patient or event information is available. The complaint receiver device was returned for evaluation. The device was visually inspected and no defect was found. The receiver failed to charge and reboot. The receiver was opened for an internal visual inspection, we observed damaged solder pins on the battery controller chip which prevented the receiver's battery from holding the charge. A known good battery was installed and a download performed. Upon review we found rtt loss followed by set time screen within the investigation window. While in the sensor session, unit shut down unexpectedly and did not recover interrupting the sensor session. Test on receiver functional test station with a good know battery passed. The reported event receiver does not hold charge was confirmed and an unexpected receiver shutdown was observed. The root cause of receiver's battery not able to hold charge is a damaged battery.
 
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Brand NameDEXCOM G4 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 Key7688149
MDR Text Key114303701
Report Number3004753838-2018-77137
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 06/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-2
Device Catalogue NumberSTK-GL-117
Device Lot Number5223577
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2018
Was Device Evaluated by Manufacturer? Yes
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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