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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 Unexpected Shutdown (4019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/18/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that unexpected receiver shutdown occurred.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
The product was evaluated.An external visual inspection was performed and passed.A receiver charge test was performed and failed due to the receiver intermittently shutting down.A receiver and boot test was performed and passed.Functional tests were not performed due to the receiver shutting down.An internal visual inspection was performed and failed due to a damaged battery.Pictures were taken.The receiver log was downloaded and reviewed finding error related to the complaint.The allegation was confirmed.The probable cause was determined to be a damaged battery.No injury or medical intervention was reported.
 
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Brand Name
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of Device
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
MDR Report Key9355704
MDR Text Key174866836
Report Number3004753838-2019-092456
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMT20649-1
Device Catalogue NumberSTK-GL-013
Device Lot Number5236953
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2020
Was the Report Sent to FDA? No
Date Manufacturer Received09/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age117 YR
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