BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2895269 · Received January 3, 2013

    Report

    Report Number
    1034569-2013-00003
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 3, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMAGE FILES SHOWED THAT (B)(6) REACTIONS WERE OBTAINED WITH THE ANTIBODY SCREENING ASSAY AND ANTIBODY IDENTIFICATION ASSAYS. RESULTS VISUALLY APPEARED (B)(6) AS REPORTED WITH BOTH HOMOZYGOUS AND HETEROZYGOUS E (B)(6) CELLS. CONTROLS PERFORMED AS EXPECTED. MANUAL TUBE TESTING WAS PERFORMED USING PEG AND (B)(6) RESULTS WERE OBTAINED. AN IMMUCOR FIELD SERVICE ENGINEER PERFORMED THE UNEXPECTED REACTION CHECKLIST. ALL PARAMETERS WERE WITHIN SPECIFICATIONS. DAILY MAINTENANCE AND QC TESTING WAS PERFORMED AND ACCEPTABLE RESULTS WERE OBTAINED. THE INSTRUMENT IS OPERATING WITHIN SPECIFICATIONS. WE WERE UNABLE TO RULE OUT A SAMPLE-RELATED ISSUE. THE REACTION STRENGTH IN MANUAL TESTING WAS (B)(6) WHICH MAY HAVE BEEN AT THE THRESHOLD OF DETECTION FOR THE ECHO.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED (B)(6) WAS OBTAINED ON GALILEO ECHO (B)(4). (B)(6) RESULTS WERE OBTAINED ON THE GALILEO NEO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3558 GALILEO ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR