BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6035387 · Received October 17, 2016

    Report

    Report Number
    3004753838-2016-66460
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    September 26, 2016
    Report Date
    September 26, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000279
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 09/26/2016, THAT ON (B)(6) 2016, THE RECEIVER DISPLAYED ERR121. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE RECEIVER HAS BEEN RECEIVED FOR DEVICE INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE RECEIVER WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND "CALL TECH SUPPORT" ERROR WAS OBSERVED ON THE SCREEN. THE DATA LOG COULD NOT BE RETRIEVED AND FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE OF THE "CALL TECH SUPPORT" ERROR. THE CUSTOMER COMPLAINT WAS CONFIRMED BECAUSE HARDWARE ERROR WAS DISPLAYED. THE ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONALLY, A MT20655 UNIVERSAL SERIAL BUS (USB) MICRO B, 3 FT, 24 AWG POWER WIRE CABLES (LOT NUMBER 2141250) WERE RETURNED. ALSO A MT21255 USB POWER SUPPLY (CHARGER) WITH USB-A RECEPTACLE, 5V 1A, US CONNECTOR ( LOT NUMBER 2140876) WERE RETURNED. AN INVESTIGATION IS NOT NECESSARY AS THESE DEVICES ARE UNRELATED TO THE CUSTOMER COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684526 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. MT22719-BLU 5214662 00386270000279

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR