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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT22719-BLU
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/25/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
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. The device has been received for investigation. A follow-up will be submitted upon completion of device investigation.
 
Manufacturer Narrative
Com-(b)(4).
 
Event Description
The receiver was returned for evaluation. An external visual inspection was performed and passed. A receiver charge and boot was performed and failed due to receiver perpetually rebooting. A receiver download was performed and an unexplained power on event was observed. The receiver case was opened, and an internal visual inspection was performed and passed. Confirmation of the complaint was confirmed. The probable cause could not be determined.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key8074153
MDR Text Key127366281
Report Number3004753838-2018-142381
Device Sequence Number1
Product Code MDS
UDI-Device Identifier10386270000276
UDI-Public10386270000276
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22719-BLU
Device Catalogue NumberSTK-RF-BLU
Device Lot Number5226609
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2017
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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