BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TS

    MDR report key: 1821573 · Received August 27, 2010

    Report

    Report Number
    1826988-2010-00577
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS UNABLE TO PROVIDE A METER SERIAL NUMBER SO IT WAS NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE.

    Description of Event or Problem · 1

    THE ADVOCATE CONTACTED CUSTOMER SERVICE ON BEHALF OF THE CUSTOMER. SHE ALLEGED THAT A CONTROL TEST WAS PERFORMED AND THE RESULT WAS 30 MG/DL. A NORMAL CONTROL RANGE WAS NOT PROVIDED, BUT SHOULD BE AROUND 100-140 MG/DL. THE CUSTOMER THEN TOOK THE CALL. HE WAS UNABLE TO PROVIDE ANY PRODUCT INFO DUE TO POOR EYESIGHT. HE ALSO DECLINED TO TROUBLESHOOT BEFORE ENDING THE CALL. NO PRODUCT WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TS NBW BAYER HEALTHCARE LLC 1801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK