BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1488305 · Received October 1, 2009

    Report

    Report Number
    1034569-2009-00330
    Event Type
    Malfunction
    Date Received
    October 1, 2009
    Date of Event
    September 3, 2009
    Report Date
    September 28, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE CALL WAS MADE. THE CAMERA READER LIGHT BULB WAS DETERIORATING; THE LIGHT BULB WAS REPLACED. THE WASHER MANIFOLD WAS REMOVED AND CLEANED. THE SYSTEM WAS TESTED, AND OPERATED WITHIN SPECIFICATIONS WITH NO PROBLEMS OBSERVED.REACTIVITY OF THE E ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY SCREEN (CRRS) I AND II, LOT X298, AND CAPTURE-R READY ID (CRRID), LOT ID118,USED BY THE CUSTOMER AT THE TIME OF THE EVENT.REACTIVITY OF THE E ANTIGEN WAS CONFIRMED ON RETURNED CRRS (I AND II), LOT X298, AND CRRID, LOT ID118. HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH CUSTOMER'S RETURNED PATIENT SAMPLE CONTAINING ANTI-E USING RETENTION PANOSCREEN I, II, AND III, LOT 28555. IMMUADD, LOT 7N5514, WAS USED AS POTENTIATOR AND TESTING WAS PERFORMED AT ALL TEMPERATURES. THE SAMPLE EXHIBITED W+ REACTIVITY AT IAT WITH E+ CELL II AND WAS NONREACTIVE WITH E-NEGATIVE CELLS I AND III.FOR SAMPLE B0019133 (REPORTED TO CONTAIN ANTI-K):2_CELL TESTING PERFORMED WITH SAMPLE USING RETENTION CRRS (I AND II), LOTS X298 AND X299 ON IN-HOUSE GALILEO. SAMPLE B0019133 WAS NONREACTIVE IN ALL TESTING. AB_ID TESTING PERFORMED USING RETENTION CRRID, LOT ID119 ON IN-HOUSE GALILEO. SAMPLE B0019133 WAS NONREACTIVE IN ALL TESTING. HEMAGGLUTINATION TUBE TESTING PERFORMED ON SAMPLE B0019133 WITH SELECTED CELLS FROM RETENTION PANOCELL-16, LOT 32600 USING IMMUADD, LOT 357004, AS A POTENTIATOR. TESTING WAS PERFORMED AT IMMEDIATE SPIN (IS), ROOM TEMPERATURE (RT), 37C AND INDIRECT ANTIGLOBULIN TEST (IAT) PHASES. SAMPLE B0019133 EXHIBITED W+ TO 1+ REACTIVITY AT 15'RT AND 1+ REACTIVITY AT 20'37C, AND IAT WITH THE K+K+ CELLS. THE SAMPLE WAS NON-REACTIVE WITH THE K- CELL, INDICATING THAT THE COLD AGGLUTININ IS NOT DETECTABLE AT THIS TIME.RESULTS INDICATE THE SAMPLE'S ANTI-K MAY BE PARTIALLY, IF NOT WHOLLY, IGM IN NATURE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY FOR THE ANTIBODY ID PANEL AND 2 CELL SCREEN ASSAYS ON THE INSTRUMENT, FOR TWO PATIENT SAMPLES ONE CONTAINING ANTI-E AND THE OTHER ANTI-K. NO ADVERSE EVENT OCCURRED AS A RESULT OF THE UNEXPECTED REACTIVITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR