BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1761003 · Received July 13, 2007

    Report

    Report Number
    1823260-2007-06116
    Event Type
    Malfunction
    Date Received
    July 13, 2007
    Date of Event
    June 29, 2007
    Report Date
    July 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE VALUES OF 94, 307, & 341 MG/DL WHEN TESTING WAS PERFORMED 2 MINUTES APART ON THE ADVANTAGE SYSTEM. REPORTER STATED HE WAS EXPERIENCING HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF THE TESTING. NO ACTIONS WERE TAKEN OR TREATMENT 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 549701

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR PREDNISONE 10YRS - 10MG ONCE DAILY| 70/30 HUMULIN 2YRS - 65 UNITS TWICE DAILY| ENBREL 3YRS - 2/200MG SHOTS ONCE WEEKLY