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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT22719-PNK
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/22/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The g5 system is associated with product code pqf.
 
Event Description
Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, the receiver was overheating. No additional event or patient information is available. The complaint device was returned for evaluation. An external visual inspection was performed and no defects were found. The receiver log was reviewed and firmware errors were observed. Functional testing was performed and the test passed. The receiver case was opened for further evaluation. An interior inspection was performed and no defects were found. Problem could not be confirmed. The root cause could not be determined.
 
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Brand NameDEXCOM G5 MOBILE 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 Key6570660
MDR Text Key75326444
Report Number3004753838-2017-26489
Device Sequence Number1
Product Code MDS
UDI-Device Identifier20386270000263
UDI-Public(01)20386270000263(241)STK-GF-PNK(10)5221990
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 04/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22719-PNK
Device Catalogue NumberSTK-GF-PNK
Device Lot Number5221990
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2016
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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