BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 640196 · Received October 6, 2005

    Report

    Report Number
    1826988-2005-00025
    Event Type
    Other
    Date Received
    October 6, 2005
    Date of Event
    September 30, 2005
    Report Date
    September 30, 2005
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED ALLEGING THAT HE OVER MEDICATED HIMSELF DUE TO FALSE READINGS. HE STATES THAT THE METER GAVE HIM A LOW READING SO ADJUSTED HIS FOOD AND MEDICATION ACCORDINGLY, ONLY TO RECEIVE YET ANOTHER LOWER READING. AN EVALUATION WAS CONDUCTED OVER THE PHONE, WHICH DETERMINED THAT THE METER WAS WORKING WITHIN SPECIFICATIONS. CUSTOMER WAS ASKED TO RETURN METER FOR FURTHER EVALUATION AND A REPLACEMENT WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other