BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1334421 · Received March 6, 2009

    Report

    Report Number
    1034569-2009-00065
    Event Type
    Malfunction
    Date Received
    March 6, 2009
    Date of Event
    February 5, 2009
    Report Date
    February 26, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE IMAGE REVEALED A REACTION IN THE A1-CELL WELL THAT APPEARED TO BE WEAKLY POSITIVE. THE ANTI-A WELL WAS NEGATIVE. REFLEXABO TESTING WAS PERFORMED WITH IN-HOUSE DONOR SAMPLES OF KNOWN ABO/RH TYPES USING RETENTION ANTI-A, LOT 101687, AND ANTI-B SERIES 3, LOT 203240, THE LOTS USED BY THE CUSTOMER, ON AN IN-HOUSE GALILEO. SOME INV WERE REPORTED DUE TO "EMPTY OR TOO DENSE WELL"; HOWEVER, ALL OTHER IN-HOUSE DONOR SAMPLES WERE INTERPRETED AS EXPECTED. NO UNEXPECTED NEGATIVES WERE OBSERVED. A SERVICE CALL WAS MADE. ISSUES WITH THE CENTRIFUGE TIMING BELT WERE OBSERVED; IT WAS REPLACED. THE SYSTEM WAS TESTED AND OPERATED WITHIN SPECIFICATIONS WITH NO PROBLEMS OBSERVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A DONOR SAMPLE WITH A HISTORY OF BEING A POSITIVE TESTED AS O POSITIVE ON THE GALILEO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1