BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1241634 · Received November 19, 2008

    Report

    Report Number
    1823260-2008-08581
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    November 2, 2008
    Report Date
    November 19, 2008
    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

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 272 MG/DL BACK TO BACK WITH A RESULT OF 132 MG/DL ON THE ADVANTAGE SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER STATED HE TOOK 2 UNITS OF REGULAR INSULIN BASED ON THE 132 MG/DL RESULT. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED.

    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 550802

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR METFORMIN - 500MG TWICE DAILY| GLIPIZIDE - 5 MG DAILY| REGULAR INSULIN - SLIDING SCALE