BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTODISC 50 TEST STRIPS

    MDR report key: 692752 · Received March 24, 2006

    Report

    Report Number
    1826988-2006-00281
    Event Type
    Malfunction
    Date Received
    March 24, 2006
    Date of Event
    March 15, 2006
    Report Date
    March 15, 2006
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RECEIVED A NORMAL CONTROL TEST RESULT OF 62 MG/DL. THE RANGE IS 110-159 MG/DL. THE CUSTOMER ALSO ALLEGED ERRATIC BLOOD GLUCOSE READINGS. THE CUSTOMER WOULD RECEIVE BLOOD GLUCOSE RESULTS OVER 400 MG/DL AND IMMEDIATELY AFTER, RESULTS IN THE 200'S (MG/DL). THE CUSTOMER DID NOT ALLEGE ANY ADVERSE EVENTS. THE STRIPS ARE TO BE RETURNED FOR EVALUATION, AND REPLACEMENT STRIPS WILL BE SENT.

    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 1A2957AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN