BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1745974 · Received August 14, 2007

    Report

    Report Number
    1823260-2007-07092
    Event Type
    Malfunction
    Date Received
    August 14, 2007
    Date of Event
    July 31, 2007
    Report Date
    August 14, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS FROM THE ADVANTAGE SYSTEM OF 122, 221, 116, & 280 MG/DL. REPORTER STATED THAT ON A DIFFERENT DAY OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS FROM THE SAME SYSTEM OF 206, 97, 126, & 101 MG/DL. NO SPECIFIC TIMEFRAME WAS PROVIDED BETWEEN THE READINGS OTHER THAN THE REFERENCE TO BACK TO BACK TESTING. NO TREATMENT INFO WAS PROVIDED AND IT WAS NOT STATED WHETHER ANY ACTIONS WERE TAKEN. 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA