BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1770875 · Received November 12, 2007

    Report

    Report Number
    1823260-2007-09826
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 8, 2007
    Report Date
    November 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER WAS TESTED AND THE CLINIC PERSONNEL OBTAINED 270MG/DL ON THE CUSTOMER'S ACCU-CHEK ADVANTAGE METER IN COMPARISON TO 83MG/DL ON THE PROFESSIONAL METER. THE RESULTS WERE OBTAINED WITHIN 10 MINUTES. NO ACTION WAS TAKEN BASED ON THE RESULTS. 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 549435

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR LABETALOL 400MG/DAY - 1 DAY| METFORMIN 1/DAY - NO LONGER ON MEDICATION| LIPITOR 40MG/DAY - 6-8MONTHS| LEVEMIR 14 UNITS/DAY - 3 DAYS| NOVOLOG 18 UNIT/DAY - 3 DAYS| BENICAR 40MG/DAY - NO LONGER ON MEDICATION| GLIPIZIDE 1/DAY - NO LONGER ON MEDICATION