BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5760354 · Received June 29, 2016

    Report

    Report Number
    3004753838-2016-96984
    Event Type
    Malfunction
    Date Received
    June 29, 2016
    Date of Event
    June 5, 2016
    Report Date
    June 5, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000279
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE RECEIVER LOG WAS REVIEWED AND SCREEN ERROR ALARMS WERE OBSERVED. THE REPORTED EVENT OF AN ERROR ICON DISPLAY WAS CONFIRMED DURING LOG REVIEW. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT THAT THE RECEIVER DISPLAYED ERR121 ON (B)(6) 2016. THE PATIENT DID NOT REPORT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412006 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT22719-BLU 5208513 00386270000279

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR