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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 DEXCOM SHARE SYSTEM

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM Back to Search Results
Model Number MT22608-BLU
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/15/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4)2017, that on (b)(6)2017, the receiver was overheating. No additional event or patient information is available. The device has been received for evaluation. A follow-up report will be submitted once the evaluation is complete.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint receiver device was returned for evaluation. An external visual inspection was performed it passed. The receiver was charged and booted, but overheats when charging. Functional testing failed due to battery not charging past 30% after three hours of charging. The receiver case was opened for an internal visual inspection and it passed. The battery was replaced with a known good battery and receiver charges and turns on without overheating (discharged known good battery to 83%; charged known good battery from 83% to 100% in <30 minutes without overheating). The receiver log was downloaded and contains "rttloss" events related to complaint. The reported event of overheating or shocking device was confirmed. The root cause was determined to be a defective lithium ion battery.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE 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 Key6720302
MDR Text Key80254140
Report Number3004753838-2017-57740
Device Sequence Number1
Product Code MDS
UDI-Device Identifier10386270000207
UDI-Public(01)10386270000207(241)STK-PR-BLU(10)5205000
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,Followup
Report Date 06/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22608-BLU
Device Catalogue NumberSTK-PR-BLU
Device Lot Number5205000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/17/2015
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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