BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1212758 · Received October 20, 2008

    Report

    Report Number
    1826988-2008-01203
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 2, 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 ADVOCATE ALLEGED THAT CONTROL TESTS WERE PERFORMED USING THE CUSTOMER'S METER AND A RESULT OF 191 MG/DL WAS RECEIVED. THE NORMAL CONTROL RANGE WAS 103-142 MG/DL. THE CUSTOMER DID NOT HAVE ANY OF THE SUSPECT TEST STRIPS LEFT, SO FURTHER TROUBLESHOOTING WAS NOT POSSIBLE. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 7151B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK