BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1181963 · Received September 22, 2008

    Report

    Report Number
    1823260-2008-07063
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN OTHER COUNTRY.

    Description of Event or Problem · 1

    CALLER REPORTEDLY RECEIVED THE FOLLOWING BLOOD GLUCOSE RESULTS ON THE COMPACT SYSTEM: 4.7 MMOL/L, 11.5 MMOL/L, AND 17.6 MMOL/L. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. PRODUCT HAS BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - NA NBW ROCHE DIAGNOSTICS 20674442

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK