BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFB III SPECIAL STAINS KIT

    MDR report key: 4180130 · Received October 15, 2014

    Report

    Report Number
    2028492-2014-00005
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 9, 2014
    Report Date
    October 15, 2014
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    KPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER IS NO LONGER COOPERATIVE. AFTER NUMEROUS ATTEMPTS TO OBTAIN INFO PATHOLOGIST REFUSED TO PROVIDE ANY FURTHER INFO OR PROVIDE THE SLIDES. CUSTOMER HAS NOT CONFIRMED ANT PT-RELATED IMPACT, DATA DETAILS, OR STATUS. NO FURTHER DETAILS ARE EXPECTED FROM THE CUSTOMER. THIS IS THE INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    SLIDES WERE RECEIVED FROM THE CUSTOMER ALLEGING ARTIFACTS ON SLIDES AND PT TISSUE. DURING THE CALL TO THE CUSTOMER TO INFORM THEM THE ISSUE WAS BEING INVESTIGATED, THE CUSTOMER REPORTED THAT, AS A RESULT OF THIS ISSUE, THEIR LAB REPORTED OUT A FALSE POSITIVE AFB RESULT. THE PT WAS TREATED FOLLOWING THEIR STANDARD PROTOCOL, AND THE MISTAKE IN DIAGNOSIS WAS NOT IDENTIFIED UNTIL SEVERAL DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655027 AFB III SPECIAL STAINS KIT AFB III KPA VENTANA MEDICAL SYSTEMS, INC. 05279437001 D11015

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other