BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTODISC 100 TEST STRIPS

    MDR report key: 1163679 · Received September 9, 2008

    Report

    Report Number
    1826988-2008-01021
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 23, 2008
    Report Date
    August 23, 2008
    Manufacturer
    BAYER HEALTHCARE LLC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HIS BLOOD GLUCOSE AND RECEIVED A READING OF 71 MG/DL USING HIS BREEZE2 METER. HE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 262 MG/DL. THE DIFFERENCE BETWEEN READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTODISC 100 TEST STRIPS BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC. 3627AC AT3621AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK