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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 DEXCOM SHARE SYSTEM

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM Back to Search Results
Model Number MT22495-BLU
Device Problems Device Issue (2379); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/18/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Clinical nurse contacted dexcom on behalf of patient on (b)(6) 2016 to report that the receiver displayed a firmware error on (b)(6) 2016. At the time of contact, no injury or medical intervention was reported. The complaint device was returned for evaluation. The device was visually inspected and no defect was found. The receiver log was reviewed and did not find any errors related to the customer complaint. The reported event of a firmware error was not confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITORING SYSTEM
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 Key5878352
MDR Text Key52180071
Report Number3004753838-2016-98054
Device Sequence Number1
Product Code MDS
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 07/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22495-BLU
Device Catalogue NumberSTK-RR-BLU
Device Lot Number5204323
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2015
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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