BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-JKA

    MDR report key: 2637342 · Received July 2, 2012

    Report

    Report Number
    1034569-2012-00128
    Event Type
    Malfunction
    Date Received
    July 2, 2012
    Date of Event
    June 4, 2012
    Report Date
    July 2, 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 WAS REFERRED TO THE PACKAGE INSERT WHICH ALLOWS FOR 1 TO 2 DROPS OF ANTISERA AND A 15 TO 30 MINUTE INCUBATION. THE CUSTOMER PERFORMED ADDITIONAL REPEAT TESTING WITH A DIFFERENT LOT AND STATED THAT 2 DROPS OF ANTI-JKA (LOT 614008) AT 30 MINUTES INCUBATION WAS ALSO POSITIVE (1+) WITH POSITIVE DONOR UNITS. CONTROLS PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIONS WITH DONOR UNITS WHEN TESTING IS PERFORMED WITH ANTI-JKA BLOOD GROUPING REAGENT, 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