BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYB

    MDR report key: 1557386 · Received December 11, 2009

    Report

    Report Number
    1034569-2009-00436
    Event Type
    Malfunction
    Date Received
    December 11, 2009
    Date of Event
    November 12, 2009
    Report Date
    December 7, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    HEMAGGLUTINATION TUBE TESTING PERFORMED WITH SELECTED FY(A+B+) AND FY(B-) CELLS FROM RETENTION PANOCELL-16 AND PANOCELL-10 USING RETENTION ANTI-FYA, LOT 613006. ALL FY(B+) CELLS EXHIBITED 2+ TO 3+ REACTIVITY AND FY(B-) CELLS WERE NONREACTIVE AS EXPECTED. HEMAGGLUTINATION TUBE TESTING PERFORMED WITH SELECTED FY(A+B+) AND FY(B-) CELLS FROM RETENTION PANOCELL-16 AND PANOCELL-10 USING RETURNED (OPENED) ANTI-FYB, LOT 613006. ALL FY(B+) CELLS EXHIBITED 2+ TO 3+ REACTIVITY AND FY(B-) CELLS WERE NONREACTIVE AS EXPECTED. HEMAGGLUTINATION TUBE TESTING PERFORMED WITH CUSTOMER'S PATIENT SAMPLE USING RETURNED AND RETENTION ANTI-FYB, LOT 613006. SAMPLE EXHIBITED 3+ REACTIVITY WITH RETURNED AND RETENTION PRODUCTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PATIENT SAMPLE WAS MISTYPED FOR FYB ANTIGEN. PATIENT SAMPLE WAS FOUND NEGATIVE WITH ANTI-FYB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-FYB BLOOD GROUPING REAGENT KSZ IMMUCOR 613006

    Patients

    Seq Age Sex Outcome Treatment
    1