BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1761017 · Received July 19, 2007

    Report

    Report Number
    1823260-2007-06328
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Date of Event
    July 11, 2007
    Report Date
    July 19, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 69 MG/DL ON ACCU-CHEK ADVANTAGE SYSTEM 1, AND 121 MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM 2, WITHIN 10 MINUTES. CUSTOMER REPORTED NO ACTION 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 549628

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR GLYBURIDE 10MG/DAY - 4 YRS