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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 MT22495
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/14/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
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.
 
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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 Key6622029
MDR Text Key76989019
Report Number3004753838-2017-44564
Device Sequence Number1
Product Code MDS
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 05/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22495
Device Catalogue NumberSTK-DR-001
Device Lot Number5215150
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 Received05/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/20/2016
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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