BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1111669 · Received August 13, 2008

    Report

    Report Number
    1823260-2008-06162
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 11, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 118 MG/DL BACK TO BACK WITH A RESULT OF 461 MG/DL ON THE ADVANTAGE SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER INDICATED THAT HE WAS FEELING SHAKY WHEN HE OBTAINED THE READINGS AND HE TOOK HIS NORMAL MEDICATION AFTERWARDS. 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 DEVICE - LFR LFR ROCHE DIAGNOSTICS 550688

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR AMARYL 4MG DAILY| LEVEMIR FLEXPEN - 25 UNITS DAILY| TYLENOL 1000MG DAILY| GLUCOPHAGE (METFORMIN) 850MG TWICE DAILY