BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1171426 · Received September 17, 2008

    Report

    Report Number
    1823260-2008-06931
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 15.5 MMOL/L, 4.8 MMOL/L, AND 11.7 MMOL/L ON THE ACTIVE SYSTEM WITHIN 10 MINS. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS-NA NBW ROCHE DIAGNOSTICS 22984332

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK