BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-JKA

    MDR report key: 4880056 · Received June 30, 2015

    Report

    Report Number
    1034569-2015-00097
    Event Type
    Malfunction
    Date Received
    June 30, 2015
    Date of Event
    May 24, 2015
    Report Date
    June 30, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102117/0.0
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMMUCOR LABORATORY TESTED RETENTION PRODUCT ON 04JUN2015. THE RETENTION PRODUCT PERFORMED AS EXPECTED. THE IMMUCOR LABORATORY ALSO TESTED RETURNED BLOOD SAMPLE (SEGMENT FROM THE DONOR UNIT IN QUESTION) ON 05JUN2015 AND 09JUN2015 THAT WAS RECEIVED FROM THE CUSTOMER SITE. THIS RETURNED BLOOD SAMPLE YIELDED THE EXPECTED POSITIVE RESULT OUTCOME.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WHEN USING POLYCLONAL ANTI-JKA, WITH TUBE TESTING METHODOLOGY, WHEN TESTED ON (B)(6) 2015, WHICH LED TO A DELAYED HEMOLYIC TRANSFUSION REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421629 ANTI-JKA BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 614010-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other