BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 5688823 · Received May 31, 2016

    Report

    Report Number
    1034569-2016-00114
    Event Type
    Malfunction
    Date Received
    May 31, 2016
    Date of Event
    May 1, 2016
    Report Date
    May 27, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001584
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON 26APR2016, IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE INSTRUMENT TEST WELL IMAGES IN QUESTION. BATCH 51119 FOR SAMPLE (B)(6) RAN AT 1552 USING R716 AND 221619 ECHO INTERPRETED ALL CELLS AS NEGATIVE. VISUALLY CELLS 1 AND 3 ARE NEGATIVE CELL 2 APPEARS VISUALLY POSITIVE CELL 2 OF R716(E+, E-,JKA-, JKB+) THE PI LAB CONFIRMED THE REACTIVITY OF THE JKB ANTIGEN ON CELL 2 OF RETENTION CAPTURE-R READY-SCREEN (3), LOT R716, ON THE ECHO, USING RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221619 AND ANTI-JKB, LOT 615006. CONTROLS PERFORMED AS EXPECTED AND ALL CELLS EXHIBITED THE EXPECTED REACTION. RETENTION PERFORMED AS EXPECTED. THE CUSTOMER WAS INFORMED OF TECHNICAL COMMUNICATION (B)(4) WHICH STATES THAT THE ECHO MAY GENERATE A NEGATIVE RESULT WITH CAPTURE-R PLATES, WHERE UPON SUBSEQUENT VISUAL INSPECTION THE CELL APPEARS WEAK POSITIVE OR EQUIVOCAL. CUSTOMER WAS ADVISED TO PERFORM A VISUAL VERIFICATION OF NEGATIVE REACTIONS BEFORE FINAL RELEASE OF THOSE WELL RESULTS.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN TESTING WITH CAPTURE-R READY SCREEN 3 (CRRS3) LOT R716 ON A GALILEO ECHO INSTRUMENT. AN ANTI-JKB WAS LATER IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342461 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC. 10888234001584

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR