BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2023794 · Received February 15, 2011

    Report

    Report Number
    1826988-2011-00062
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) CUSTOMER CALLED FOR HELP WITH TROUBLESHOOTING HIS CONTOUR METER. HE PERFORMED CONTROL TESTS AND REC'D A RESULT OF 1.8 MMOL/L. A NORMAL CONTROL RANGE WAS NOT PROVIDED, BUT SHOULD BE AROUND 6.0-8.2 MMOL/L. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER USED THE LAST OF THE TEST STRIPS WHILE TROUBLESHOOTING, SO NO PRODUCT WILL BE RETURNED. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE, LLC 7152B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK