BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1163661 · Received September 9, 2008

    Report

    Report Number
    1826988-2008-01004
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT SHE PERFORMED A CONTROL TESTS USING HER CONTOUR METER AND RECEIVED A READING OF 185 MG/DL. A CONTROL RANGE WAS NOT PROVIDED, BUT IT SHOULD BE AROUND 100-138 MG/DL. THE CUSTOMER HAD A HARD TIME HEARING OVER THE PHONE, SO SHE DECLINED TO TROUBLESHOOT THE METER AND TEST STRIPS. SHE ENDED THE CALL AND ASKED THAT CUSTOMER SERVICE CONTACT HER THE NEXT DAY. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER, BUT THEY WERE NOT SUCCESSFUL. NO PRODUCT WILL BE RETURNED.

    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