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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 Inappropriate or Unexpected Reset (2959)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018 the receiver initialized without a manual restart. No additional event or patient information is available. No product or data were provided for evaluation. The report of the receiver initializing without manual restart could not be determined. A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint receiver device was returned for evaluation. The device was visually inspected and no defect was found. The receiver was charged and was perpetually rebooting. The receiver was opened and the ui pcba was detached to perform a download. The receiver log was reviewed and errors were observed. Functional testing was unable to be performed due to perpetual rebooting. The reported event of initializing screen without manual restart was confirmed during log review. 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
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key7904255
MDR Text Key121595888
Report Number3004753838-2018-112497
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 09/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2018
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 Number5233420
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2017
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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