BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYA

    MDR report key: 983845 · Received January 25, 2008

    Report

    Report Number
    1034569-2008-00017
    Event Type
    Malfunction
    Date Received
    January 25, 2008
    Date of Event
    December 24, 2007
    Report Date
    January 22, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    13068 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    TESTED RETENTION PANOSCREEN I AND II, LOT 45317, AND SELECTED FY(A+B+) AND FY(A-B+) REAGENT RED CELLS FROM PANOCELL-20, LOT 45290 ,WITH RETENTION ANTI-FYA, LOT FYA63H-1. THE EXPECTED REACTIVITY WAS OBSERVED IN ALL TESTING. RETURNED ANTI-FYA, LOT FYA63H-1 WAS TESTED WITH SELECTED REAGENT RED CELLS FROM PANOCELL-20, LOT 48368. THE EXPECTED REACTIVITY WAS OBSERVED IN ALL TESTING.

    Description of Event or Problem · 1

    A CUSTOMER PHENOTYPED 2 UNITS OF BLOOD FOR THE FYA ANTIGEN WITH ANTI-FYA LOT FYA63H-1 USING TUBE TESTING. ONE UNIT WAS INCOMPATIBLE WITH A PATIENT SAMPLE DURING CROSSMATCH USING GEL METHODOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-FYA BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. FYA63H-1

    Patients

    Seq Age Sex Outcome Treatment
    1