BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-JKB

    MDR report key: 5419825 · Received February 9, 2016

    Report

    Report Number
    1034569-2016-00024
    Event Type
    Malfunction
    Date Received
    February 9, 2016
    Date of Event
    January 13, 2016
    Report Date
    February 9, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102118/0.0
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL JKB ANTIGEN TESTING WAS USING ONE (1) DROP OF ANTISERUM INCUBATED FOR FIFTEEN (15) MINUTES. WHEN USING THIS REAGENT, USERS ARE PERMITTED TO USE TWO (2) DROPS OF ANTISERUM INCUBATED FOR THIRTY (30) MINUTES, AS DESCRIBED IN THE PACKAGE INSERT. WHEN TESTING WAS SUBSEQUENTLY REPEATED USING TWO (2) DROPS OF ANTISERUM INCUBATED FOR THIRTY (30) MINUTES, AS DESCRIBED IN THE PACKAGE INSERT, THEN THE CORRECT EXPECTED POSITIVE JKB ANTIGEN POSITIVE OUTCOMES WERE OBTAINED BY THE CUSTOMER SITE. THIS EVENT WAS COVERED IN LABELING. THE PRODUCT WAS PERFORMING AS EXPECTED WITH THIS SUBSEQUENT REPEAT TESTING USING THE LONGER INCUBATION TIME AND AN ADDITIONAL DROP OF ANTISERUM. THEREFORE NO ADDITIONAL PRODUCT INVESTIGATION WAS REQUIRED. \ PRODUCT PERFORMED WITHIN TEST METHOD.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WHEN USING ANTI-JKB POLYCLONAL ANTISERUM WITH MANUAL TESTING METHODOLOGY, WHICH LED TO A DELAYED HEMOLYTIC TRANSFUSION REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76569 ANTI-JKB BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 615009

    Patients

    Seq Age Sex Outcome Treatment
    1 Other