BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONOTORING SYTEM

    MDR report key: 3771297 · Received April 24, 2014

    Report

    Report Number
    3004753838-2014-05510
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 26, 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

    DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT THAT ON (B)(6) 2014 A PATIENT EXPERIENCED A MISSING SENSOR WIRE. AFTER SENSOR FAILURE, PATIENT REMOVED SENSOR. UPON SENSOR REMOVAL, PATIENT NOTICED THAT THE WIRE WAS MISSING. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249338 G4 PLATINUM CONTINUOUS GLUCOSE MONOTORING SYTEM MDS MDS DEXCOM, INC 9500-27 5076133

    Patients

    Seq Age Sex Outcome Treatment
    1 Other