BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK VOICEMATE

    MDR report key: 1781066 · Received July 25, 2007

    Report

    Report Number
    1823260-2007-06505
    Event Type
    Malfunction
    Date Received
    July 25, 2007
    Date of Event
    July 18, 2007
    Report Date
    July 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K982079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S ROOMMATE REPORTING THAT THE ACCU-CHEK VOICEMATE SYSTEM SPOKE 165 MG/DL WHILE THE ACCU-CHEK ADVANTAGE METER SCREEN DISPLAYED 93 MG/DL. NO ACTION WAS TAKEN BASED ON THE READINGS. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK VOICEMATE BLOOD GLUCOSE MONITORING DEVICE - LFR LFR ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR