BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R SELECT

    MDR report key: 1171475 · Received September 24, 2008

    Report

    Report Number
    1034569-2008-00472
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 24, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSS
    PMA / PMN Number
    BK040024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED A SAMPLE (REPORTED TO CONTAIN ANTI-VEL), IT WAS TESTED WITH PANOSCREEN, LOT 28317, USING IMMUADD AS THE POTENTIATOR. INCUBATIONS AT IS AND RT WERE INCLUDED. NO REACTIVITY WAS OBSERVED AT IS OR RT. VARIABLE REACTIVITY WAS OBSERVED AT IAT. THE CUSTOMER'S SAMPLE WAS ALSO TESTED WITH CAPTURE-R READY SCREEN (CRRS), LOT G140, AND CAPTURE-R SELECT, LOT SC050. THE SAMPLE WAS REACTIVE WITH CELL IV ON CRRS. THE SAMPLE WAS REACTIVE WITH ALL CELLS ON SELECT, LOT SC050. NO VEL-NEGATIVE DONOR CELLS WERE AVAILABLE FOR TESTING. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION, THE RESULTS APPEAR TO BE DUE TO THE NATURE OF THE SAMPLE.

    Description of Event or Problem · 1

    DURING GALILEO VALIDATION, UNEXPECTED NEGATIVE REACTIONS WERE OBSERVED USING CAPTURE-R SELECT. EIGHTY DONORS WERE TESTED AND HALF OF THEM DEMONSTRATED POSITIVE REACTIVITY WHEN TESTED WITH A SERUM KNOW TO CONTAIN ANTI-VEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R SELECT SOLID PHASE RED CELL ADHERENCE ASSAY KSS IMMUCOR, INC. SC050

    Patients

    Seq Age Sex Outcome Treatment
    1