BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO NEO

    MDR report key: 5564912 · Received April 8, 2016

    Report

    Report Number
    1034569-2016-00068
    Event Type
    Malfunction
    Date Received
    April 8, 2016
    Date of Event
    March 6, 2016
    Report Date
    April 8, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK100033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMMUCOR PRODUCT INVESTIGATIONS LAB PERFORMED AN AG_CCE ASSAY ON KNOWN RH IN HOUSE DONOR SAMPLES, ON THE NEO, USING RETENTION ANTI-C GAMMACLONE, LOT 936130. CONTROLS PERFORMED AS EXPECTED AND ALL IN HOUSE DONOR SAMPLES RESULTED AS EXPECTED. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED. NO PRODUCT OR SAMPLES WERE RETURNED FOR ADDITIONAL INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIONS ON GALILEO NEO (B)(4) WHEN USING BLOOD GROUPING REAGENT, ANTI-C GAMMA-CLONE, LOT 936130.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220069 GALILEO NEO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1