BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-JKA

    MDR report key: 2602708 · Received June 7, 2012

    Report

    Report Number
    1034569-2012-00109
    Event Type
    Malfunction
    Date Received
    June 7, 2012
    Date of Event
    May 8, 2012
    Report Date
    June 7, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IS USING 1 DROP OF ANTI-JKA BLOOD GROUPING REAGENT TO PERFORM MANUAL TESTING AND INCUBATING AT 37C FOR 15 MINUTES. THE PACKAGE INSERT RECOMMENDS 1 TO 2 DROPS AND INCUBATION FOR 15 TO 30 MINUTES AT 37C. TESTING WAS PERFORMED BY TWO DIFFERENT TECHNOLOGISTS. THE CUSTOMER INSTRUCTED THE TECHNOLOGISTS TO USE TWO DROPS OF ANTISERA AS THE DROP SIZE FOR THE ANTISERA APPEARS TO BE SMALLER THAN OTHER ANTISERA AND MAY VARY DEPENDING ON HOW THE DROPPER IS HELD. IN-HOUSE TESTING WAS PERFORMED BY IMMUCORS PRODUCT INVESTIGATIONS LAB WHICH CONFIRMED THE REACTIVITY OF RETENTION ANTI-JKA, LOT 614007-1 BY TESTING THE ANTISERA WITH FOUR JK(A+B+) AND FOUR JK(A-B+) REAGENT RED BLOOD CELLS FROM RETENTION PANOCELL-20 , LOT 12576. CONTROLS PERFORMED AS EXPECTED AND REAGENT RED BLOOD CELLS EXHIBITED THE EXPECTED REACTIVITY. RETENTION PRODUCT PERFORMED AS EXPECTED. NO PRODUCT DEFICIENCIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIONS WHEN TESTING DONOR UNITS WITH BLOOD GROUPING REAGENT ANTI-JKA, LOT 614007-1.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1