BEUDAMED
    FDA Adverse Event Summary report: N

    PANOCELL-10

    MDR report key: 1012829 · Received March 17, 2008

    Report

    Report Number
    1034569-2008-00065
    Date Received
    March 17, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 10, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESENCE OF THE FYB ANTIGENT WAS CONFIRMED ON RETENTION CELL # 1 PANOCELL-10, LOT 03470. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY WITH CELL 1 OF PANOCELL 10 LOT 03470, USED AS A POSITIVE CONTROL FOR FYB ANTIGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANOCELL-10 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. 03470

    Patients

    Seq Age Sex Outcome Treatment
    1