BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR CELLS

    MDR report key: 1396923 · Received June 3, 2009

    Report

    Report Number
    1034569-2009-00183
    Event Type
    Malfunction
    Date Received
    June 3, 2009
    Date of Event
    May 5, 2009
    Report Date
    May 21, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE FYA ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY SCREEN (CRRS)(POOLED CELLS), LOT N197, USING RETENTION CAPTURE-R READY INDICATOR CELLS (CRRIC), LOT 221365, USED BY THE CUSTOMER AT THE TIME OF THE EVENT. THE CUSTOMER'S SAMPLE WAS RECEIVED WITH 3+ HEMOLYSIS; THEREFORE, NO TESTING WAS PERFORMED ON THE GALILEO INSTRUMENT. THE SAMPLE WAS TESTED BY MANUAL SOLID PHASE WITH RETENTION CRRS(POOLED CELLS), LOT N197, USING RETENTION CRRIC, LOT 221365. THE SAMPLE WAS NONREACTIVE. THE SAMPLE WAS TESTED BY TUBE HEMAGGLUTINATION TESTS USING RETENTION PANOSCREEN I, II AND III, LOT 14367, USING IMMUADD AS THE POTENTIATOR. A ROOM TEMPERATURE INCUBATION WAS INCLUDED. THE SAMPLE WAS NONREACTIVE IN ALL PHASES OF TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON THE GALILEO FOR A PATIENT SAMPLE KNOWN TO CONTAIN ANTI-FYA .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY INDICATOR CELLS AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR 221365

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR