BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1236890 · Received November 21, 2008

    Report

    Report Number
    1034569-2008-00560
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 20, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE K ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY-SCREEN (POOLED), LOT N174, THE LOT USED BY THE CUSTOMER AT THE TIME OF THE EVENT. MANUAL TESTING WAS PERFORMED WITH THE CUSTOMER'S RETURNED PATIENT SAMPLE (3+ HEMOLYSIS) USING RETENTION CAPTURE-R READY-SCREEN (POOLED), LOT N174, CAPTURE-R READY-SCREEN (I AND II), LOT X260 (FOR COMPARISION PURPOSES), AND CAPTURE-R INDICATOR RED CELLS, LOT 221264. THE SAMPLE WAS NONREACTIVE IN ALL TESTRING. THE CUSTOMER'S PATIENT SAMPLE WAS TESTED WITH RETENTION PANOSCREEN I, II, AND III, LOT 34914, USING IMMUADD AS THE POTENTIATOR, BY HEMAGGLUTINATION TUBE TESTING. THE SAMPLE WAS NONREACTIVE WITH ALL CELLS IN ALL TESTING, INCLUDING MICROSCOPIC IAT.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT A DONOR SAMPLE WAS TESTED ON THE GALILEO FOR THE POOL CELL ASSAY AND PRODUCED A NEGATIVE RESULT. THE SAMPLE WAS THEN TESTED USING THE GEL METHODOLOGY AND A 2+ RESULT WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR