BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (10)

    MDR report key: 1578349 · Received January 12, 2010

    Report

    Report Number
    1826988-2009-01130
    Event Type
    Malfunction
    Date Received
    January 12, 2010
    Date of Event
    December 17, 2009
    Report Date
    December 17, 2009
    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

    THE CUSTOMER CALLED FOR ASSISTANCE WITH PERFORMING A CONTROL TEST. HE RECEIVED A RESULT OF 402 MG/DL. THE NORMAL CONTROL RANGE WAS 103-142 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 (10) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 9507C 8BC3C55

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK