BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8663169 · Received June 3, 2019

    Report

    Report Number
    3013756811-2019-29571
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 10, 2019
    Report Date
    June 3, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM USER GUIDE, ¿THE TRANSMITTER IS REUSABLE AND IS REPLACED ABOUT EVERY 3 MONTHS.¿ NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A FAILED TRANSMITTER ERROR. REPORTEDLY, THE TRANSMITTER HAD BEEN IN USE MORE THAN 3 MONTHS. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. TANDEM TECHNICAL SUPPORT INSTRUCTED THE CUSTOMER TO USE A NEW TRANSMITTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455125 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR