BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2895283 · Received January 3, 2013

    Report

    Report Number
    1034569-2013-00004
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 7, 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
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PERFORM ADDITIONAL TESTING FOR FURTHER INVESTIGATION AND REQUESTED SERVICE. AN IMMUCOR FIELD SERVICE ENGINEER PERFORMED THE UNEXPECTED REACTION CHECKLIST. ALL PARAMETERS WERE WITHIN SPECIFICATIONS. QC PERFORMED AS EXPECTED. THE INSTRUMENT IS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE REACTIVITY WAS OBTAINED ON GALILEO ECHO (B)(4). AN ANTI-C WAS IDENTIFIED ON THE GALILEO NEO WHICH WAS IN THE PROCESS OF BEING VALIDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273 GALILEO ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1