BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1024228 · Received March 27, 2008

    Report

    Report Number
    1826988-2008-00312
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE CALLED ON BEHALF OF A CUSTOMER. HE STATED THAT HE TESTED THE CUSTOMER'S BLOOD GLUCOSE AND RECEIVED RESULTS OF 27.3, 18.7, AND 13.0 MMOL (491, 337, AND 234 MG/DL). THE TESTS WERE TAKEN ONE AFTER THE OTHER. THE ADVOCATE STATED THAT THE CUSTOMER HAD SUFFERED 2 STROKES SINCE THE METER WAS LAST REPLACED. HE ALLEGED THE STROKES COULD HAVE BEEN PREVENTED IF THE METER WAS WORKING CORRECTLY. THE CUSTOMER REFUSED TO TROUBLESHOOT THE METER AND ENDED THE CALL. ATTEMPTS WILL BE MADE TO CONTACT THE CUSTOMER AND TROUBLESHOOT THE CONTOUR SYSTEM. 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 7152 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK