BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTODISC 50 TEST STRIPS

    MDR report key: 1001174 · Received February 15, 2008

    Report

    Report Number
    1826988-2008-00191
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 30, 2008
    Report Date
    January 30, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HIS BLOOD GLUCOSE AND RECEIVED A READING OF 219 MG/DL USING HIS BREEZE2 METER. HE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 102 MG/DL. THE DIFFERENCE BETWEEN THE 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 50 TEST STRIPS BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 3622A 1A3412AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK