BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1001162 · Received February 15, 2008

    Report

    Report Number
    1826988-2008-00197
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 31, 2008
    Report Date
    January 31, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE READINGS HAD BEEN HIGHER THAN USUAL. THE CUSTOMER DID NOT HAVE NORMAL CONTROL SOLUTION, SO HE PERFORMED CONTROL TESTS USING THE HIGH CONTROL. HE RECEIVED A RESULT OF 447 MG/DL, BUT THE HIGH CONTROL RANGE WAS 293-405 MG/DL. 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 CONTOUR TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 7098B 7GCB01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK