BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1021828 · Received March 27, 2008

    Report

    Report Number
    1826988-2008-00323
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE HAD BEEN RECEIVING HIGH GLUCOSE READINGS USING HIS CONTOUR METER. HE ALLEGED THAT HE PERFORMED A CONTROL TEST AND REC'D A RESULT OF 200 MG/DL. THE CUSTOMER HAD DISPOSED OF HIS TEST STRIPS, BUT THE NORMAL CONTROL TEST RANGE SHOULD HAVE BEEN AROUND 100-140 MG/DL. THE CUSTOMER DID NOT ALLEGE ANY ADVERSE EVENTS. NO PROD IS AVAILABLE FOR RETURN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK