BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1464280 · Received September 9, 2009

    Report

    Report Number
    1034569-2009-00301
    Event Type
    Malfunction
    Date Received
    September 9, 2009
    Date of Event
    August 10, 2009
    Report Date
    September 8, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK 040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF CUSTOMER INSTRUMENT IMAGES CONFIRMED THE UNEXPECTED RESULTS.ABORH TESTING WAS PERFORMED WITH IN-HOUSE DONOR SAMPLES OF KNOWN ABO/RH TYPES USING RETENTION ANTI-A, LOT 101701, ANTI-B SERIES 3, LOT 203271, ANTI-D SERIES 4, LOT 504731, AND ANTI-D SERIES 5, LOT 505551ON AN IN-HOUSE GALILEO. THE SAME LOTS OF REAGENTS WERE USED BY THE CUSTOMER. ALL IN-HOUSE DONOR SAMPLES TYPED AS EXPECTED. ABORH TESTING WAS PERFORMED WITH IN-HOUSE DONOR SAMPLES OF KNOWN ABO/RH TYPES AND CUSTOMER'S PATIENTS' SAMPLE USING RETENTION ANTI-A, LOT 101701, ANTI-B SERIES 3, LOT 203271, ANTI-D SERIES 4, LOT 504731, ANTI-D SERIES 5, LOT 505551, RETURNED ANTI-D SERIES 4, LOT 504731 (UNOPENED), A1 REFERENCELLS, AND B REFERENCELLS ON AN IN-HOUSE GALILEO. ALL IN-HOUSE DONOR SAMPLES TYPED AS EXPECTED. RETURNED PATIENT SAMPLE WAS TESTED ON THE IN-HOUSE GALILEO, AND WAS INTERPRETED AS O POSITIVE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PREVIOUSLY KNOWN O POSITIVE PATIENT SAMPLE TYPED AS O NEGATIVE 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 57 YR