BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYB

    MDR report key: 1010502 · Received March 13, 2008

    Report

    Report Number
    1034569-2008-00057
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 7, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102116 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    HEMAGGLUTINATION TUBE TESTING PERFORMED WITH RETENTION ANTI-FYB, LOTS FYB69H-1, AND FYB70H-1, USING FY(A+B+) AND FY(B-) REAGENT RED CELLS, INCLUDING CELL #13 FROM RETENTION PANOCELL-16, LOT 51402. NO UNEXPECTED NEGATIVE REACTIVITY WAS OBSERVED. PANOCELL-16, LOT 51402, EXPIRED BEFORE RETURNED PRODUCT WAS RECEIVED. THE CUSTOMER DID NOT RETURN SAMPLES FOR INVESTIGATION TESTING. HEMAGGLUTINATION TUBE TESTING PERFORMED WITH RETURNED (OPENED) ANTI-FYB, LOT FYB70H-1, USING FY(A+B+) AND FY(B-) REAGENT RED CELLS FROM RETENTION PANOCELL-20, LOT 04478. NO UNEXPECTED NEGATIVE REACTIVITY WAS OBSERVED. ALL FY(B+) CELLS EXHIBITED 1+S TO 2+S REACTIVITY AND ALL FY(B-) CELLS WERE NONREACTIVE WITH RETURNED ANTI-FYB.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH ANTI-FYB, LOT FYB70H-1, WHEN TESTING WITH CELL #13, HETEROZYGOUS FYB CELL, OF PANOCELL-16, LOT #51402.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-FYB BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. FYB70H-1

    Patients

    Seq Age Sex Outcome Treatment
    1