BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-JKA

    MDR report key: 3966002 · Received July 30, 2014

    Report

    Report Number
    1034569-2014-00132
    Event Type
    Malfunction
    Date Received
    July 30, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 29, 2014
    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

    CONFIRMED THE REACTIVITY OF RETENTION ANTI-JKA, LOT 614009 WITH CELLS 5, 6, 10, AND 11 OF RETENTION PANOCELL-20, LOT 21483. CONTROLS PERFORMED AS EXPECTED AND ALL REAGENT RED CELLS EXHIBITED THE EXPECTED REACTIVITY. CELLS THAT REPORTED POSITIVE, EXHIBITED POSITIVE REACTIVITY OF 2+. RETENTION PRODUCT PERFORMED AS EXPECTED. PERFORMED A PHENOTYPE ASSAY ON CUSTOMER'S SUBMITTED SAMPLE, (B)(6) (TUBES A AND B), BY TUBE METHOD USING RETENTION ANTI-JKA, LOT 614009. CONTROLS PERFORMED AS EXPECTED AND CUSTOMER'S SAMPLE EXHIBITED 2+ POSITIVE REACTIVITY. CONFIRMED THE REACTIVITY OF RETURNED ANTI-JKA, LOT 614009 BY TUBE METHOD WITH CELLS 5, 6, 10, AND 11 OF RETENTION PANOCELL-20 LOT 21483. CONTROLS PERFORMED AS EXPECTED. CELLS 5 AND 6 RESULTED THE EXPECTED POSITIVE, EXHIBITING POSITIVE REACTIVITY OF 1+, AND CELLS 10 AND 11 RESULTED THE EXPECTED POSITIVE, EXHIBITING POSITIVE REACTIVITY OF 2+. IMMUCOR WAS NOT ABLE TO REPRODUCE THE COMPLAINT. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN USING ANTI-JKA WITH TUBE TESTING METHODOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444835 ANTI-JKA BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 614009

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Death| L