BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 1884931 · Received October 26, 2010

    Report

    Report Number
    MW5017909
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    October 26, 2009
    Report Date
    October 26, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BOOKLET SAYS SENSOR CAN BE UP TO 20% OFF. FOR MORE THAN 9 MONTHS, SENSOR HAS BEEN >20% INACCURATE 90% OF THE TIME. PT STOPPED USING DEVICE, THEN RESTARTED. SENSOR IS NOW OFF 100% OF THE TIME. PT RECEIVED FALSE HIGH AND LOW RESULTS. PT LOST CONSCIOUSNESS IN STREET AND WENT INTO A COMA. PT STATES "DOES SOMEBODY NEED TO DIE BEFORE THEY TAKE THIS OFF THE MARKET?" MFR SENDS NEW SENSORS TO FIX PROBLEM. RECENTLY, CUSTOMER WAS TOLD THAT THERE WAS NOTHING ELSE THAT COULD BE DONE TO HELPING ME BY THE MFR. NO CALIBRATION ERROR WAS GIVEN BY THE PUMP DURING INACCURACIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED SENSOR MDS MEDTRONIC MINIMED H260

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other| R