BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANOCELL-16

    MDR report key: 1522521 · Received November 6, 2009

    Report

    Report Number
    1034569-2009-00393
    Event Type
    Malfunction
    Date Received
    November 6, 2009
    Date of Event
    October 9, 2009
    Report Date
    November 5, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH N+ AND N- CELLS FROM RETENTION PANOCELL-16, LOT 36653, USING RETENTION ANTI-N. ALL PRODUCTS PERFORMED AS EXPECTED. HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH N+ AND N- CELLS FROM RETURNED PANOCELL-16, LOT 36653, USING RETENTION ANTI-N. ALL PRODUCTS PERFORMED AS EXPECTED. THE N- CELL WAS NONREACTIVE AND ALL N+ CELLS EXHIBITED 3+ TO 4+ REACTIVITY. HEMAGGLUTINATION TUBE TESTING PERFORMED WITH CUSTOMER'S PATIENT SAMPLE (REPORTEDLY ANTI-JSA,-V,-C,-E,-N,-FYA,-FYB,-JKB,-S AND WAA) USING ALL N+ CELLS FROM RETURNED AND RETENTION PANOCELL-16, LOT 36653. ONE N- CELL WAS TESTED FROM RETENTION PANOCELL-16. SAMPLE EXHIBITED 3+ TO 4+ REACTIVITY WITH ALL RETURNED AND RETENTION N+ CELLS AND WAS NONREACTIVE WITH THE ONE N- CELL OF RETENTION LOT 36653 TESTED. PRODUCTS PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED MISSED ANTI-N ANTIBODY USING PANOCELL-16 TO TEST A PATIENT SAMPLE WITH A KNOWN ANTI-N. PATIENT WAS NOT TRANSFUSED USING SAMPLE IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANOCELL-16 REAGENT RED BLOOD CELLS KSZ IMMUCOR 36653

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR