BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 7611842 · Received June 18, 2018

    Report

    Report Number
    1034569-2018-00143
    Event Type
    Malfunction
    Date Received
    June 18, 2018
    Date of Event
    April 23, 2018
    Report Date
    May 23, 2018
    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

    IMMUCOR FIELD SERVICE WAS CALLED TO ASSESS THE GALILEO ECHO INSTRUMENT. FIELD SERVICE INSPECTED THE INSTRUMENT ON (B)(6) 2018 AND PERFORMED UNEXPECTED REACTION CHECKLIST. ALL TESTS PASSED EXCEPT FOR THE PERI-PUMP WHICH HAD A READING 9.29G. THE TECHNICIAN REPLACED THE TUBING AND THE TEST PASSED AT 10.9G. THE TECHNICIAN THEN RAN QC AND 7 PATIENT SAMPLES WHICH WERE ALL SUCCESSFUL. CUSTOMER WAS ABLE TO REPEAT SCREEN TEST OF SAMPLE ID (B)(4) ON (B)(6) 2018WITH CAPTURE-R READY SCREEN LOT NUMBER R968 AND CAPTURE-R INDICATOR CELLS LOT NUMBER 221085, OBTAINING 3+ RESULTS ON CELL 2 AS EXPECTED AFTER IMMUCOR FIELD SERVICE HAD CHANGED PUMP TUBING.

    Description of Event or Problem · 1

    ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN AND IDENTIFICATION, WHEN TESTED ON A GALILEO ECHO INSTRUMENT ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453217 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC. 10888234001584

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR