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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 MT20649-1
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/25/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the receiver was overheating. No product or data was provided for evaluation. Confirmation of the allegation and a probable cause could not be determined. No injury or medical intervention was reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Subsequent to the initial mdr, a correction is required.
 
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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
ashley spoto
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key9506191
MDR Text Key172417107
Report Number3004753838-2019-111052
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-1
Device Catalogue NumberSTK-GL-007
Device Lot Number5253346
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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