BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYB

    MDR report key: 1422894 · Received July 30, 2009

    Report

    Report Number
    1034569-2009-00255
    Event Type
    Malfunction
    Date Received
    July 30, 2009
    Date of Event
    June 30, 2009
    Report Date
    July 27, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    102115 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THEY DID NOT WASH THE DONOR CELLS ONCE BEFORE ADDING THE REAGENT. THE PACKAGE INSERT INDICATES THE CELLS SHOULD BE WASHED PRIOR TO ADDING THE REAGENT. CUSTOMER WAS ASKED TO WASH THE DONOR CELLS PRIOR TO ADDING THE REAGENT PER THE PACKAGE INSERT.THE CUSTOMER DID NOT RETURN SAMPLE FOR TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NOT GETTING STRONG REACTIVITY USING ANTI-FYB WITH CONTROLS, THAT CONSEQUENTLY CAUSED MISTYPING OF TWO UNITS.TWO UNITS THAT WERE CALLED FALSE NEGATIVE FOR THE FYB ANTIGEN WERE SENT FOR FURTHER MANUFACTURING USE; NOT FOR TRANSFUSION USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-FYB BLOOD GROUPING SERA KSZ IMMUCOR 613004

    Patients

    Seq Age Sex Outcome Treatment
    1