BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1040965 · Received May 8, 2008

    Report

    Report Number
    1823260-2008-03837
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 26, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINED A DISCREPANT BLOOD GLUCOSE RESULT OF 400 MG/DL BACK TO BACK WITH A RESULT OF 111 MG/DL ON THE ADVANTAGE SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER INDICATED THAT HE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. REPORTER STATED THAT HE RAN CONTROLS ON THE SYSTEM AND OBTAINED ERRORS FOR BOTH LEVELS. 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 550090

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR UNK INSULIN - 2 MONTHS / 30 UNITS DAILY| GLYBURIDE - ABOUT 30 YEARS / 2.5MG TWICE DAILY