BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFILL TEST STRIPS (50)

    MDR report key: 862670 · Received July 6, 2006

    Report

    Report Number
    1826988-2006-00813
    Event Type
    Malfunction
    Date Received
    July 6, 2006
    Date of Event
    June 10, 2006
    Report Date
    June 10, 2006
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONTACT STATED THE CUSTOMER'S METER HAS BEEN READING ERRATICALLY. THE CUSTOMER TESTED HER BLOOD GLUCOSE BACK TO BACK AND RECEIVED READINGS OF 143, 363, AND 36 MG/DL. THE DIFFERENCE BETWEEN THESE READINGS FALLS IN THE "C" AND "D" ZONES OF THE PARKES ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. THE CONTACT DID NOT ALLEGE THE CUSTOMER EXPERIENCED ANY ADVERSE EVENTS DUE TO THE READINGS. THE METER AND STRIPS ARE TO BE RETURNED FOR EVALUATION, AND REPLACEMENT PRODUCTS WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROFILL TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 7080 5EB3B05

    Patients

    Seq Age Sex Outcome Treatment
    1 YR