BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6552784 · Received May 8, 2017

    Report

    Report Number
    3004753838-2017-37732
    Event Type
    Malfunction
    Date Received
    May 8, 2017
    Date of Event
    April 12, 2017
    Report Date
    April 12, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    10386270000238
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERR121. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE RECEIVER WAS RETURNED FOR EVALUATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND USB DOOR FELL OFF. THE RECEIVER DATA LOG WAS DOWNLOADED AND REVIEWED AND FIRMWARE ERRORS 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) CABLES (LOT NUMBER 2153074 AND 2152044) 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
    333625 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. MT22719 5218139 10386270000238

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR