BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1235020 · Received November 20, 2008

    Report

    Report Number
    1034569-2008-00558
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 20, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS RECEIVED AFTER PRODUCTS EXPIRED. RETENTION CAPTURE-R INDICATOR CELLS LOT 221149 AND ANTI-D SERIES 4, LOT 504697X HAD BEEN TESTED AND PERFORMED AS EXPECTED. THE CUSTOMER DID NOT RETURN SAMPLE FOR INVESTIGATION TESTING. IT IS NOT POSSIBLE TO RULE OUT THE SAMPLE AS A CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN RH DISCREPANCY ON THE GALILEO. THE PATIENT ORIGINALLY RESULTED AS B POSITIVE (WEAK D POSITIVE) AND THE SECOND DONATION TESTED AS B NEGATIVE (WEAK D NEGATIVE).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR