BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR LINK

    MDR report key: 1062692 · Received June 18, 2008

    Report

    Report Number
    1826988-2008-00638
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 5, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE READINGS HAD BEEN HIGHER THAN USUAL WHEN TESTING WITH HIS CONTOUR LINK METER. HE RECEIVED READINGS OF 29 AND 30 MMOL/L (522 AND 540 MG/DL) AND "HI". HE RETESTED USING 2 OTHER METERS AND RECEIVED READINGS OF 7 AND 8 MMOL/L (126 AND 144 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 CUSTOMER REFUSED TO TROUBLESHOOT OVER THE PHONE. THE METER AND TEST STRIPS ARE TO BE RETURNED FOR EVAL. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA CONTOUR LINK BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 9588 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK