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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 11/26/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The patient experienced adverse events on different days with the same device. The following reports are being submitted. (b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018 the receiver shutdown unexpectedly. No additional event or patient information is available. No product was provided for evaluation. The complaint confirmation of the receiver ceasing to function could not be determined. A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The product was evaluated. The device was externally visually inspected and it passed. The receiver failed to charge and reboot. The receiver did not turn on. The battery was replaced with a known good battery and the receiver turned on. The log was downloaded, there was no data within the investigation window. The receiver case was opened, the internal inspection passed. The battery was inspected and it failed due to low voltage. Confirmation of the allegation and a root cause could not be determined.
 
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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 Key8182924
MDR Text Key131048450
Report Number3004753838-2018-159381
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-1
Device Catalogue NumberSTK-GL-010
Device Lot Number5223319
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2017
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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