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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR Back to Search Results
Model Number MT22719-BLU
Device Problem Failure to Charge (1085)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The g5 system is associated with product code pqf.
 
Event Description
Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017 the receiver will not charge. No additional event or patient information is available. Complaint device was returned for evaluation. A visual exterior inspection was performed on the receiver and it passed. The reciever was charged and a boot test was performed on the reciever, finding the receiver perpetualy rebooting. The receiver case was opened and an interior inspection was performed and it passed. Data logs were downloaded and reviewed, finding a screen error alarm, in addition to a hardware error and a firmware error. Based on the findings of a firmware error this is now reportable. The complaint of the reciever not charging was confirmed. The root cause was determined to be ui-u1 board related failures, post investigation.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS 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
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key6546677
MDR Text Key74489786
Report Number3004753838-2017-38532
Device Sequence Number1
Product Code MDS
UDI-Device Identifier30386270000270
UDI-Public(01)30386270000270(241)STK-GF-BLU(10)5220960
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
Report Date 04/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22719-BLU
Device Catalogue NumberSTK-GF-BLU
Device Lot Number5220960
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2016
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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