BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1771975 · Received November 2, 2007

    Report

    Report Number
    1823260-2007-09550
    Event Type
    Malfunction
    Date Received
    November 2, 2007
    Date of Event
    October 13, 2007
    Report Date
    November 2, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED RESULTS 326 MG/DL AND 117 MG/DL WITHIN 10 MINUTES ON THE ACCU-CHEK ADVANTAGE SYSTEM. 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 COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549830

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR LISINOPRIL 5 MG/DAY| GLYBURIDE 5 MG/DAY