BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO NEO

    MDR report key: 2754439 · Received September 21, 2012

    Report

    Report Number
    1034569-2012-00174
    Event Type
    Malfunction
    Date Received
    September 21, 2012
    Date of Event
    August 23, 2012
    Report Date
    September 21, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK100001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN IMMUCOR FIELD SERVICE ENGINEER ADJUSTED THE REAGENT PROBE AT THE RIGHT PIPETTE POSITION; RE-TEACHED RIGHT TARGET; AND REPLACED REAGENT SYRINGE PLUNGER. THE PIPTEST PERFORMED WITHIN SPECIFICATIONS. AN ABO QC AND 3-CELL QC WERE PERFORMED. TESTED FULL PLATES OF ABO AND 1 NTD SAMPLE; RE-TESTED 12 SAMPLES AND REPLACED NTD SAMPLE WITH ACCEPTABLE RESULTS. THE NEO IS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED POSITIVE REACTIVITY ON THE GALILEO NEO WITH BLOOD GROUPING REAGENT ANTI-B SERIES 3, LOT 203440.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1