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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 MT20649-2
Device Problem Unexpected Shutdown (4019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that an unexpected receiver shutdown occured. No product or data was provided for evaluation. Confirmation of the allegation and root cause could not be determined. No injury or medical intervention was reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The product was evaluated. The device was externally visually inspected and it passed. The receiver failed to charge but was able to be rebooted. The log was downloaded and reviewed finding an error related to the complaint. The receiver case was opened, the internal inspection failed due to a damaged battery. The allegation was confirmed. The root cause was determined to be a damaged battery.
 
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Brand NameDEXCOM G4 PLATINUM 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
ying chen
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key8470843
MDR Text Key140643820
Report Number3004753838-2019-30593
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 04/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-2
Device Catalogue NumberSTR-GL-102
Device Lot Number5224499
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2017
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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