BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 4769833 · Received May 13, 2015

    Report

    Report Number
    1034569-2015-00077
    Event Type
    Malfunction
    Date Received
    May 13, 2015
    Date of Event
    April 16, 2015
    Report Date
    May 13, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO CONNECT TO THE CUSTOMER SITE INSTRUMENT IN QUESTION, TO VIEW THE TEST WELL IMAGES. BATCH 5125 TESTED ON (B)(6) 2015 USING LOTS ID239, 221312. NEGATIVE REACTIONS FOR CELLS 5 (FYA= FYB+, JKA+ JKB=), 9 (FYA+ FYB=, JKA+ JKB=), 11 (FYA= FYB+, JKA+ JKB=), 12 (FYA= FYB+, JKA+ JKB=), AND 13 (FYA= FYB=, JKA+ JKB=), VISUALLY NEGATIVE EXCEPT CELL 9 WHICH IS VISUALLY EQUIVOCAL. POSITIVE REACTIONS FOR CELLS 1 (FYA= FYB+, JKA + JKB+), 2 (FYA+ FYB=, JKA= JKB+), 3 (FYA+ FYB=, JKA= JKB+), 4 (FYA= FYB=, JKA+ JKB+), 6 (FYA= FYB+, JKA= JKB+), 7 (FYA+ FYB+,JKA= JKB+), 8 (FYA= FYB+, JKA+ JKB+), 10 (FYA+ FYB+, JKA+ JKB+), AND 14 (FYA= FYB+ JKA+ JKB+), ALL 4+, VISUALLY POSITIVE. CONTROLS REACTED AS EXPECTED. CELL 9 IS THE ONLY CELL FYA+ AND JKB=, IT WAS VISUALLY EQUIVOCAL. NO OTHER SAMPLES IN THIS BATCH. BATCH 5127 TESTED ON (B)(6) 2015 USING LOTS DP077, 221312. NEGATIVE REACTIONS FOR CELLS 5 (FYA+ FYB+, JKA+ JKB=), 7 (FYA+ FYB=, JKA+ JKB=), 8 (FYA+ FYB=, JKA+ JKB=), AND 13 (FYA= FYB+, JKA+ JKB=). CELLS 5, 7 AND 8 ARE VISUALLY EQUIVOCAL, CELL 13 IS VISUALLY NEGATIVE. POSITIVE REACTIONS FOR CELLS 1 (FYA= FYB+, JKA= JKB+), 2 (FYA+ FYB=, JKA+ JKB+), 3 (FYA= FYB+, JKA= JKB+), 4 (FYA= FYB+, JKA+ JKB+), 6 (FYA+ FYB+, JKA+ JKB+), 9 (FYA+ FYB=, JKA+ JKB+), 10 (FYA= FYB+, JKA= JKB+), 11 (FYA+ FYB+, JKA+ JKB+), 12 (FYA+ FYB+, JKA= JKB+)AND 14 (FYA+ FYB+, JKA+ JKB+), ALL 4+, ALL VISUALLY POSITIVE. CONTROLS REACTED AS EXPECTED. CELLS 5, 7, AND 8 ARE FYA+ JKB=, ALL 3 WERE VISUALLY POSITIVE. NO OTHER SAMPLES IN THIS BATCH.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTION WITH CAPTURE-R READY-ID (CRRID) AND CAPTURE-R READY-ID EXTEND I ON THE GALILEO ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313613 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR