BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1220070 · Received October 31, 2008

    Report

    Report Number
    1823260-2008-08077
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 570 MG/DL, 204 MG/DL, AND 588 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. REPORTER ALLEGED THAT WITHIN 10 MINUTES OF THE 204 MG/DL AND 588 MG/DL RESULTS, SHE OBTAINED ANOTHER RESULT OF 235 MG/DL ON THE SAME SYSTEM. REPORTER STATED THAT 15 MINUTES AFTER ALL OF THE READINGS, SHE TOOK HER NORMAL 850 MG OF METFORMIN AND 15 MG OF ACTOS. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 550539

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR METFORMIN| ACTOS