BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 692819 · Received March 24, 2006

    Report

    Report Number
    1826988-2006-00266
    Event Type
    Malfunction
    Date Received
    March 24, 2006
    Date of Event
    March 13, 2006
    Report Date
    March 13, 2006
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE RECEIVED SEVERAL ERRATIC READINGS WITHIN MINUTES OF EACH OTHER. THE READING WERE AS FOLLOWS: 287, 212, 187, AND 106 MG/DL. THE DIFFERENCE BETWEEN 287 AND 106 MG/DL FALLS IN THE "C" ZONE OFR THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE CUSTOMER DID NOT ALLEGE ANY ADVERSE EVENTS. THE METER AND STRIPS ARE TO BE RETURNED FOR EVALUATION, AND A REPLACEMENT METER AND STRIPS WILL BE SENT.

    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 UNKNOWN