BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONOTORING SYTEM

    MDR report key: 3771513 · Received April 24, 2014

    Report

    Report Number
    3004753838-2014-05490
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 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'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT THAT ON (B)(6) 2014 PATIENT EXPERIENCED A MISSING SENSOR WIRE. AFTER DEPLOYMENT, THE NEEDLE WAS EXPOSED WITH SENSOR WIRE STILL INSIDE. NO MEDICAL INTERVENTION WAS REQUIRED. DEXCOM HAS ISSUED AN RGA FOR PATIENT TO RETURN DEVICE TO BE INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248994 G4 PLATINUM CONTINUOUS GLUCOSE MONOTORING SYTEM MDS MDS DEXCOM, INC 9500-27 5132244

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other