BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-S

    MDR report key: 1031637 · Received April 22, 2008

    Report

    Report Number
    1034569-2008-00115
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 15, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102140 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PANOCELL-10, LOT 01448, AND PANOCELL-16, LOT 02454 EXPIRED PRIOR TO RECEIPT OF THE CUSTOMER'S COMPLAINT; THEREFORE, NO ADDITIONAL SEROLOGICAL TESTING WAS PERFORMED WITH THESE LOTS. THE REACTIVITY OF THE S ANTIGEN ON PANOCELL-10, LOT 01448, AND PANOCELL-16, 02454, WAS VERIFIED THROUGH LOT RELEASE RECORDS. IN HOUSE TESTING WAS PERFORMED WITH ANTI-S, LOT SC72N-1 AND SELECTED S+S+ AND S- REAGENT RED CELLS FROM RETENTION PANOCELL-16, LOT 06506. THE EXPECTED REACTIVITY WAS OBSERVED IN ALL TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH ANTI-S ANTISERA, LOT #SC72N-1, EXP. 2/28/09. DURING TESTING WITH AN S POSITIVE CELL, NEGATIVE REACTIONS WERE OBSERVED WHEN TESTING CELL #2, HETEROZYGOUS S CELL, AND CELL #7, HOMOZYGOUS S CELL, OF PANOCELL-16 LOT #02454. CELL #7 OF PANOCELL-10, LOT #01448 ALSO RESULTED AS NEGATIVE. IN ADDITION, 6 OUT OF 8 DONOR UNITS RESULTED AS NEGATIVE WHEN TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-S BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. SC73N-1

    Patients

    Seq Age Sex Outcome Treatment
    1