BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 3800830 · Received May 8, 2014

    Report

    Report Number
    1034569-2014-00075
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 8, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Removal / Correction Number
    1034569-5/8/2014-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014 AN IMMUCOR ECHO GLOBAL SUPPORT ENGINEER (GSE) DISCOVERED THAT THE WASH CYCLE RAN ONLY ONCE INSTEAD OF THE EXPECTED FOUR CYCLES DURING THE CAPTURE-R READY-SCREEN (CRRS) AND CAPTURE-R READY-ID (CRRID) ASSAYS ON ECHO (B)(4). INSPECTION OF THE PROFILES.INI FILE FOUND THAT WASH PROFILE 12 WAS MISSING. THE MOST LIKELY CAUSE WAS USE OF AN ARCHIVE DISK POSSESSING THE PROFILES.INI VERSION 1.0 TO COMPLETE THE BACK UP OF A REPLACEMENT PC. THIS OPERATION WAS PERFORMED IN (B)(4) 2010. THIS IMPACTS BOTH THE SCREEN & READY-ID PROFILES. TOO FEW WASHES IN CRRS AND CRRID ASSAYS CAN CAUSE INSUFFICIENT REMOVAL OF PLASMA PROTEIN AND LEAD TO NEUTRALIZATION OF THE CAPTURE-R READY INDICATOR RED CELLS, CAUSING INVALID TEST RESULTS; PARTIAL NEUTRALIZATION MAY RESULT IN UNEXPECTED NEGATIVE REACTIONS. THE ASSAY FILE VERSIONS ON ECHO (B)(4) WERE CORRECTED TO THE CURRENT VERSION ON (B)(4) 2014. THE CUSTOMER WAS NOTIFIED OF THE CORRECTION VIA THE SERVICE REPORT. IMMUCOR'S CORRECTION REPORT (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WHEN TESTING A SAMPLE WITH A KNOWN ANTIBODY WITH CAPTURE-R READY ID (CRRID) ON THE GALILEO ECHO INSTRUMENT. THE CUSTOMER ALSO REPORTED QC FAILURES IN THE POSITIVE CONTROL WELL OF CAPTURE-R READY-SCREEN 3 (CRRS3) PLATES WHEN TESTING PATIENT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278581 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1