BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO NEO

    MDR report key: 5878925 · Received August 16, 2016

    Report

    Report Number
    1034569-2016-00209
    Event Type
    Malfunction
    Date Received
    August 16, 2016
    Date of Event
    July 19, 2016
    Report Date
    August 16, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001041
    PMA / PMN Number
    BK100033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF CUSTOMER'S INSTRUMENT IMAGES: CRRID LOT ID301 CELLS 4 AND 13 ARE EXPECTED NEGATIVES, ALL OTHER CELLS SHOULD BE POSITIVE CELL 1 C+C-, K-, FYA+FYB+, S+S-. CELL 2 C=C-, K-, FYA+FYB+, S-. CELL 3 C-, K-, FYA+FYB+, S-. CELL 5 C+C+, K-, FYA-, S-. CELL 6 C-, K-, FYA-, S+S+. CELL 7 C-, K+, FYA+FTB-, S+S+. CELL 8 C-, K+ FYA-, S+S+. CELL 9 C-, K-, FYA+FYB-, S-. CELL 10 C-, K-, FYA+FYB-, S-. CELL 11 C-, K-, FYA+FYB-, S+S-. CELL 12 C-, K+, FYA+FYB-, S-. CELL 14 C+C-, K-, FYA+FYB-, S-. A SERVICE CALL WAS MADE: INSPECTED INSTRUMENT AND FOUND LEAKING OCCURRING AT THE TUBING FOR THE PROBE RINSE STATION RESOLUTION - REPLACED THE PBS CONTAINER AND CAP TO REMOVE AIR LEAK CAUSING A DECREASE IN ACTIVE WASH.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON A PATIENT SAMPLE (SAMPLE (B)(6)) WHEN TESTING WITH CAPTURE-R READY-ID (CRRID) ON THE GALILEO NEO INSTRUMENT. THE PATIENT HAS PREVIOUSLY IDENTIFIED ANTI-C, ANTI-K, ANTI-S AND ANTI-FYA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533280 GALILEO NEO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC. 10888234001041

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR