BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1559892 · Received December 15, 2009

    Report

    Report Number
    1034569-2009-00447
    Event Type
    Malfunction
    Date Received
    December 15, 2009
    Date of Event
    November 20, 2009
    Report Date
    December 15, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK 040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INSTRUMENT IMAGES WAS PERFORMED. THE SAMPLE TESTED NEGATIVE FOR ALL 14 CELLS. POSITIVE AND NEGATIVE CONTROLS PERFORMED AS EXPECTED. CONFIRMED THE REACTIVITY OF THE JKA ANTIGEN ON RETENTION CRRID, LOT ID121, WITH ANTI-JKA. CONFIRMED THE REACTIVITY OF THE JKA ANTIGEN ON RETURNED CRRID, LOT ID121, WITH ANTI-JKA. AB_ID ASSAY PERFORMED WITH CUSTOMER'S PATIENT SAMPLE (PLASMA) USING RETURNED AND RETENTION CRRID, LOT ID121 ON IN-HOUSE GALILEO. SAMPLE EXHIBITED 2+ REACTIVITY WITH JK(A+B+) CELL 7, ON RETURNED PRODUCT AND WAS NONREACTIVE WITH ALL OTHER CELLS. HEMAGGLUTINATION TUBE TESTING PERFORMED WITH CUSTOMER'S PATIENT SAMPLE (SERUM) USING SELECTED JK(A+B+), JK(A+B-), AND JK(A-) CELLS FROM RETENTION PANOCELL-10. SAMPLE EXHIBITED VERY WEAK (+W) REACTIVITY WITH JK(A+B-) CELL AND WAS NONREACTIVE IN ALL OTHER TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTION WHEN TESTING A SAMPLE WITH AN ANTI-JKA WITH CAPTURE-R READY ID (CRRID) 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 82 YR