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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-BLU
Device Problems Overheating of Device (1437); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/25/2017
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. No product was provided for evaluation. The reported event of receiver was overheating could not be confirmed. A root cause cannot be determined. It was reported that the device was exposure to moisture or humidity. Labeling indicates; keep the receiver dry. Do not spill fluids on it or drop it into fluids. Keep the micro usb port cover closed to help prevent fluid from getting inside the receiver.
 
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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 Key6581055
MDR Text Key75603191
Report Number3004753838-2017-26403
Device Sequence Number1
Product Code MDS
UDI-Device Identifier20386270000273
UDI-Public(01)20386270000273(241)STR-GF-BLU(10)5220969
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 04/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22719-BLU
Device Catalogue NumberSTR-GF-BLU
Device Lot Number5220969
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/07/2016
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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