BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1771225 · Received February 18, 2008

    Report

    Report Number
    1823260-2008-01622
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    December 14, 2007
    Report Date
    February 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K930979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE ADVANTAGE METER PRODUCED A RESULT OF HI (GREATER THAN 600 MG/DL) WITH NO BLOOD ON THE TEST STRIP. NO ACTION TAKEN ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR LISINOPRIL - 17 YEARS 40MG/DAY| HYDROCODONE - 17 YEARS 5MG/500/DAY| NIFEDIPINE - 17 YEARS 30MG/DAY| ZOCOR - 17 YEARS 40MG/DAY| ATENOLOL - 17 YEARS 25MG/DAY| ASPIRIN - 325MG/DAY| HUMALOG 70/30 - 17 YEARS 36 UNITS/DAY| HUMALOG 70/30 - 17 YEARS 45 UNITS/DAY| LORAZEPAM - 17 YEARS 15MG/DAY| CITALOPRAM - 17 YEARS 40MG/AS NEEDED