BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8641850 · Received May 24, 2019

    Report

    Report Number
    3013756811-2019-28240
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    May 4, 2019
    Report Date
    May 24, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR OVER ONE HOUR. REPORTEDLY, THE PUMP AND TRANSMITTER REGAINED CONNECTION. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433814 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR