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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
Device Problem No Display/Image (1183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/01/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, the receiver displays only the back light. No additional patient or event information is available. The complaint device was returned for evaluation. The device was visually inspected and no defect was found. Functional and drop testing was performed and there was no failure detected related to the complaint. The receiver log was reviewed and a firmware error and a screen error alert were observed. The reported event of no receiver display except backlight was confirmed during log review. A root cause could not be determined. Based on the investigation results this issue has been upgraded from non-reportable to reportable.
 
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Brand NameDEXCOM G5 MOBILE 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 Key6634931
MDR Text Key77513549
Report Number3004753838-2017-38677
Device Sequence Number1
Product Code MDS
UDI-Device Identifier10386270000238
UDI-Public(01)10386270000238(241)STK-GF-001(10)5219350
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 05/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22719
Device Catalogue NumberSTK-GF-001
Device Lot Number5219350
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2016
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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