BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE

    MDR report key: 1002660 · Received February 8, 2008

    Report

    Report Number
    1823260-2008-01380
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 27, 2008
    Report Date
    February 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORT STATES THAT THE CUSTOMER OBTAINED A 200 MG/DL AND 98 MG/DL BLOOD GLUCOSE COMPARISON ON THE ACCU-CHEK ACTIVE SYSTEM. THE REPORTER STATES THAT THE CUSTOMER OBTAINED AN ADDITIONAL COMPARISON WITH BLOOD GLUCOSE RESULTS 200 MG/DL AND 80 MG/DL ON THE ACCU-CHEK ACTIVE S SYSTEM. ON BOTH OCCASIONS, TEST RESULTS WERE OBTAINED WITHIN 10 MINUTES. NO ACTION WAS TAKEN BASED ON THE READINGS. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 22963733

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR