BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1032096 · Received April 18, 2008

    Report

    Report Number
    1826988-2008-00473
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL ALLEGED THAT SHE PERFORMED A CONTROL TEST AND REC'D A RESULT OF 200 MG/DL. THE NORMAL CONTROL RANGE WAS 97-134 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER SERVICE REPRESENTATIVE OFFERED TO SENT A REPLACEMENT BOTTLE OF TEST STRIPS AND CONTROL SOLUTION SINCE THE OPEN DATE WAS NOT KNOWN. THE CALLER DECLINED THE OFFER AND STATED THAT SHE WOULD CALL BACK IF THERE WERE ANY OTHER ISSUES. 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 7151B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK