BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1770556 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09191
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    September 29, 2007
    Report Date
    October 22, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE ACCU-CHEK ADVANTAGE SYSTEM 1. REFERENCE MEDWATCH WITH (B)(4) FOR SUSPECT DEVICE ACCU-CHEK ADVANTAGE SYSTEM 2.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED RESULTS 253 MG/DL ON ACCU-CHEK ADVANTAGE SYSTEM 1 AND 103 MG/DL ON ACCU-CHEK ADVANTAGE SYSTEM 2 WITHIN 10 MINUTES. 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 DEVICE - LFR LFR ROCHE DIAGNOSTICS 549532

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR METFORMIN - 1000 MG/DAY - 27 YEARS| FELODIPINE - 20 MG/DAY - 12 YEARS| GLYBURIDE - 10 MG/DAY - 27 YEARS| FINASTERIDE - 5 MG/DAY - 9 MONTHS| LISINOPRIL - 80 MG/DAY - 12 YEARS