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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 MT22495-BLU
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/25/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the receiver was overheating. No additional event or patient information is available. No product or data was provided for evaluation. The complaint confirmation of the overheating of the receiver could not be determined. A probable cause could not be determined.
 
Manufacturer Narrative
Com-(b)(4).
 
Event Description
The receiver was returned for evaluation. An exterior visual inspection was performed and failed. The usb port connector was found to be contaminated. A charge of the unit was attempted and it failed to charge and boot. The data log was attempted to download, however could not be performed. The receiver case was opened for an interior inspection, and failed. The moisture damage was observed. The complaint was confirmed for receiver overheating due to a defective receiver u5. The probable cause was determined to be defective receiver u5.
 
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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 Key7353383
MDR Text Key102908388
Report Number3004753838-2018-028401
Device Sequence Number1
Product Code MDS
UDI-Device Identifier10386270000177
UDI-Public10386270000177
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 02/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22495-BLU
Device Catalogue NumberSTK-DR-BLU
Device Lot Number5222047
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2016
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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