BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANOCELL-20

    MDR report key: 1862763 · Received October 8, 2010

    Report

    Report Number
    1034569-2010-00214
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNOLOGIST ERROR CANNOT BE RULED OUT. REPEAT TESTING RESULTED POSITIVE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTION WITH CELL 6 (HOMOZYGOUS JKA) OF PANOCELL-20 WHEN TESTING PATIENT SAMPLE CONTAINING ANTI-JKA, ANTI-FYA AND ANTI-S. ALL OTHER JKA POSITIVE CELLS WERE ALSO POSITIVE FOR FYA AND S AND RESULTED POSITIVE. NEGATIVE REACTION WITH CELL 6, HOMOZYGOUS JKA CELL, RULED OUT THE ANTI-JKA. NO ADVERSE REACTIONS OCCURRED AS A RESULT OF THE UNEXPECTED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANOCELL-20 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. 29304

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR