BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINGERSTIX

    MDR report key: 271851 · Received March 22, 2000

    Report

    Report Number
    1810909-2000-00010
    Event Type
    Malfunction
    Date Received
    March 22, 2000
    Date of Event
    November 1, 1999
    Report Date
    March 21, 2000
    Manufacturer
    BAYER CORP.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT IS AN INFECTION CONTROL OFFICER AT A HOSP. INFECTION CONTROL OFFICER TOLD A BAYER AUTHORIZED SALES REPRESENTATIVE THAT ON THREE OCCASIONS, MEMBERS OF INFECTION CONTROL OFFICER'S STAFF WERE INADVERTENTLY PUNCTURED AFTER USING A FINGERSTIX. THE COMPLAINANT WAS CONTACTED AND A REVIEW OF THE EVENT WAS MADE. INFECTION CONTROL OFFICER INDICATED THAT TWO OF THE THREE EVENTS OCCURRED LATE LAST YEAR AND ONE THE WEEK OF 2/14/00. IN ALL CASES, THE LANCET SEPARATED FROM THE END CAP AND AN EMPLOYEE WAS ACCIDENTALLY STUCK. IN ONE CASE, THE USER OF THE FINGERSTIX MISHANDLED THE DEVICE AND INFECTION CONTROL OFFICER BELIEVES THIS CONTRIBUTED TO THE ACCIDENTAL STICK. A REVIEW OF WHAT LOT NUMBER OF FINGERSTIX COULD HAVE BEEN IN PLACE AT THE TIME OF THE EVENT WAS CONDUCTED. THE COMPLAINANT INDICATED THAT INFECTION CONTROL OFFICER COULD NOT DETERMINE WITH ANY DEGREE OF ACCURACY WHAT LOT NUMBERS MAY HAVE BEEN IN PLACE SINCE THESE ITEMS ARE NOT LOT TRACED AT THE HOSP. THEREFORE, INVESTIGATION INTO THIS MATTER IS NOT PRACTICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINGERSTIX LANCET FMK BAYER CORP. 5965 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN