BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-C (MONOCLONAL) SERIES 1

    MDR report key: 1097855 · Received August 7, 2008

    Report

    Report Number
    1034569-2008-00301
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 9, 2008
    Report Date
    August 6, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    103480 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR C+C+ AND FOUR C+C- FROM RETENTION PANOCELL-16, LOT 24774 AND PANOCELL-10, LOT 23766 WERE TESTED ,WITH RETENTION ANTI-C, LOT 945002. THE EXPECTED REACTIVITY WAS OBSERVED IN ALL TESTING. THE CUSTOMER'S RETURNED SAMPLE WAS TESTED WITH RETENTION ANTI-C LOT 945002 AND ANTI-C LOT 7B733 (POLYCLONAL). THE SAMPLE EXHIBITED ROUGH TO WEAK REACTIVITY AFTER 5' 37C INCUBATION AND WEAK TO MODERATE REACTIVITY AFTER ADDITIONAL 10' 37C INCUBATION WITH ANTI-C LOT 945002. THE SAMPLE WAS NONREACTIVE AT IS AND EXHIBITED WEAK TO MODERATE REACTIVITY WITH ANTI-C LOT 7B733 ONLY AFTER 15' 37 C INCUBATION. THE CUSTOMER'S COMPLAINT APPEARS TO BE RELATED TO THE NATURE OF THE SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON A DONOR UNIT TESTED WITH ANTI-C SERIES 1. NEGATIVE REACTIONS WERE OBSERVED AFTER 5 MINUTES INCUBATION AT 37C AND AFTER 10 MINUTES INCUBATION AT 37C. THIS DONOR UNIT WAS SHIPPED TO A CONSIGNEE AND WAS TYPED AT CONSIGNEE AS C POSITIVE AND CONSEQUENTLY RETURNED TO CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-C (MONOCLONAL) SERIES 1 BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 945002

    Patients

    Seq Age Sex Outcome Treatment
    1