BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1770941 · Received November 13, 2007

    Report

    Report Number
    1823260-2007-09905
    Event Type
    Malfunction
    Date Received
    November 13, 2007
    Date of Event
    October 26, 2007
    Report Date
    November 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    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 BLOOD GLUCOSE RESULTS OF 10 MG/DL BACK TO BACK WITH A RESULT OF 100 MG/DL WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES ON THE ACTIVE S SYSTEM. NO ACTIONS WERE REPORTEDLY TAKEN OR TREATMENT RECEIVED. 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 ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 22965931

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR FOLIC ACID, 1 YR - DOSAGE UNK, ONCE DAILY| PRILOSEC, 6 MOS - DOSAGE UNK, ONCE DAILY| ENBREL, 1 MO - 50ML ONCE WEEKLY| METHOTREXATE, 2 YRS - 5MG ONCE WEEKLY| METFORMIN - 500MG TWICE DAILY