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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 MT22608-PNK
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/04/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, the receiver was overheating. No additional event or patient information is available. The receiver was returned for evaluation. An exterior visual inspection was performed and passed. A charge and boot test was performed and the receiver failed to charge. The receiver was observed to become unusually hot during the charging test. The receiver log was downloaded and reviewed, and errors relevant to the customer complaint were found in the investigation window. Functional testing was performed and the receiver failed the initial battery test. The receiver was opened for further investigation. An internal visual inspection was performed and passed. The receiver was plugged into a charging source and the u5 main board was observed to become unusually hot during charging. The customer complaint of the overheating of the receiver was confirmed. The probable cause was determined to be a defective u5 main board.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key7233101
MDR Text Key98763052
Report Number3004753838-2018-011120
Device Sequence Number1
Product Code MDS
UDI-Device Identifier10386270000191
UDI-Public10386270000191
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 01/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22608-PNK
Device Catalogue NumberSTK-PR-PNK
Device Lot Number5220790
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2016
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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