BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2142660 · Received June 21, 2011

    Report

    Report Number
    1826988-2011-00338
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 19, 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
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER SERIAL NUMBER PROVIDED WAS NOT VALID, SO IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE.

    Description of Event or Problem · 1

    A PHARMACIST CONTACTED BAYER ON BEHALF OF A CUSTOMER. THE CUSTOMER ALLEGED THAT SHE PERFORMED A CONTROL TEST USING HER CONTOUR SYS AND RECEIVED A RESULT OF 40 MG/DL. A NORMAL CONTROL RANGE WAS NOT PROVIDED, BUT SHOULD BE AROUND 106 - 147 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER HAD ALREADY DISPOSED OF THE TEST STRIPS, SO FURTHER TROUBLESHOOTING WAS NOT POSSIBLE. NO PRODUCT WILL BE RETURNED. THE PHARMACY REPLACED THE CUSTOMER'S METER, SO A REPLACEMENT WAS SENT TO THE PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE, LLC 7151H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK