BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-JKA

    MDR report key: 2498157 · Received March 21, 2012

    Report

    Report Number
    1034569-2012-00051
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    February 23, 2012
    Report Date
    March 21, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS ADVISED TO PERFORM REPEAT TESTING WITH A NEW VIAL OF ANTISERA. HOWEVER, NO ADDITIONAL SAMPLE WAS AVAILABLE. IN-HOUSE TESTING WAS PERFORMED ON RETENTION ANTI-JKA, LOT 614007, BY TESTING THE ANTISERA WITH FOUR JK (A+B+) AND FOUR JK (A-B+) REAGENT RED BLOOD CELLS FROM RETENTION PANOCELL-16, LOT 52408. CONTROLS PERFORMED AS EXPECTED AND REAGENT RED BLOOD CELLS TESTED EXHIBITED THE EXPECTED REACTIVITY. RETENTION PRODUCTS PERFORMED AS EXPECTED. THE VIAL OF ANTI-JKA, LOT 614007, RETURNED BY THE CUSTOMER WAS TESTED WITH FOUR JK (A+B+) AND FOUR JK(A-B+) REAGENT RED BLOOD CELLS FROM RETENTION PANOCELL-16, LOT 04458. CONTROLS PERFORMED AS EXPECTED AND REAGENT RED BLOOD CELLS EXHIBITED THE EXPECTED REACTIVITY. RETURNED PRODUCTS PERFORMED AS EXPECTED. THERE WERE NO PRODUCT DEFICIENCIES IDENTIFIED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE REACTIONS WERE OBTAINED WHEN TESTING A PATIENT'S SAMPLE WITH ANTI-JKA, LOT 614007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-JKA BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 614007

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR