BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1772024 · Received September 18, 2007

    Report

    Report Number
    1823260-2007-08185
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    August 27, 2007
    Report Date
    September 18, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULT OF HI (GREATER THAN 600 MG/DL) ON THE ADVANTAGE SYSTEM AND 110 MG/DL ON PROFESSIONAL'S DEVICE WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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 COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549210

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HUMULIN 70/30 - 97 UNITS AM - 2 YEARS| HUMULIN 70/30 - 95 UNITS PM - 2 YEARS