BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONOTORING SYTEM

    MDR report key: 3652135 · Received February 27, 2014

    Report

    Report Number
    3004753838-2014-03481
    Event Type
    Malfunction
    Date Received
    February 27, 2014
    Date of Event
    February 2, 2014
    Report Date
    February 3, 2014
    Manufacturer
    DEXCOM, INC
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014 PATIENT EXPERIENCED HARDWARE FAILURE. PATIENT WAS ADVISED TO RESTART DEVICE OM (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122364 G4 PLATINUM CONTINUOUS GLUCOSE MONOTORING SYTEM MDS MDS DEXCOM, INC MT22460 5046378

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other