BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1030411 · Received April 15, 2008

    Report

    Report Number
    1826988-2008-00443
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 4, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO DETERMINE A MANUFACTURE DATE WITHOUT A METER SERIAL NUMBER.

    Description of Event or Problem · 1

    THE ADVOCATE STATED THAT HE TESTED HIS BLOOD GLUCOSE USING THE CUSTOMER'S CONTOUR AND RECEIVED A READING OF 183 MG/DL. HE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 78 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE ADVOCATE DID NOT HAVE THE CUSTOMER'S TESTING SUPPLIES WITH HIM AT THE TIME OF THE CALL, SO TROUBLESHOOTING WAS NOT POSSIBLE. NO PRODUCT WILL BE RETURNED AT THIS TIME.

    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