BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 974523 · Received January 4, 2008

    Report

    Report Number
    1826988-2008-00007
    Event Type
    Malfunction
    Date Received
    January 4, 2008
    Date of Event
    December 7, 2007
    Report Date
    December 7, 2007
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HOME HEALTH NURSE CALLED ON BEHALF OF THE CUSTOMER. HE STATED THAT THE CUSTOMER HAD BEEN RECEIVING LOW BLOOD GLUCOSE READINGS. WHILE TROUBLESHOOTING, HE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 31 MG/DL. THE NORMAL CONTROL RANGE WAS 103-147 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVAL. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7080D 7DC3C08

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK