BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1083895 · Received July 28, 2008

    Report

    Report Number
    1823260-2008-05820
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 75 MG/DL, 224 MG/DL, 78 MG/DL AND 211 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. REPORTER STATED THAT AT A DIFFERENT TIME, SHE OBTAINED THE RESULTS OF 116 MG/DL AND 238 MG/DL ON THE SAME SYSTEM WITHIN 10 MINUTES. NO 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 550546

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR LANTUS - 1 YEAR| GUANFACINE - 9 MONTHS 1MG DAILY| APIDRA - 1 YEAR| ACTOS - 5 YEARS| FUROSEMIDE - 2 YEARS| ASPIRIN - 5 YEARS| OMEGA 3 - 1.5 YEARS| SYNTHROID - 5 YEARS| MICARDIS - 2 YEARS| "SPIRONOLACT" - 9 MONTHS| TEKTURNA - 9 MONTHS| LIPITOR