BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5505936 · Received March 16, 2016

    Report

    Report Number
    3004753838-2016-33797
    Event Type
    Malfunction
    Date Received
    March 16, 2016
    Date of Event
    February 15, 2016
    Report Date
    February 21, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000279
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) DESCRIBE EVENT OR PROBLEM - ADDITIONAL, DEVICE AVAILABLE FOR EVALUATION - ADDITIONAL, ADDITIONAL INFORMATION/DEVICE EVALUATION, DEVICE EVALUATED BY MANUFACTURER - ADDITIONAL, EVENT PROBLEM AND EVALUATION CODES - ADDITIONAL.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT THAT THE RECEIVER DISPLAYED ERR121 ON (B)(6) 2016. THE PATIENT'S MOTHER DID NOT REPORT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    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. ADDITIONALLY TWO UNIVERSAL SERIAL BUS (USB) CORDS WERE RETURNED (2132955) (2132956) HOWEVER, THESE DEVICES ARE UNRELATED TO THE CUSTOMER COMPLAINT, THEREFORE AN INVESTIGATION IS NOT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159853 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT22719-BLU 5204523 00386270000279

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR