BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 775879 · Received August 30, 2006

    Report

    Report Number
    1034569-2006-00098
    Event Type
    Malfunction
    Date Received
    August 30, 2006
    Date of Event
    August 8, 2006
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    bk040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATA IMAGES FROM THE CUSTOMER'S INSTRUMENT WERE RETRIEVED AND REVIEWED. THE SPECIMEN APPEARED TO BE O, RH NEGATIVE. THE CUSTOMER RETURNED THE SPECIMEN FOR INVESTIGATION TESTING. THE SPECIMEN TESTED AS O, RH POSTIVE ON AN IN-HOUSE GALILEO. THE SPECIMEN WAS FURTHER TESTED WITH VARIOUS ANTI-D REAGENTS, INCLUDING RETENTION ANTI-D SERIES 4, LOT 504687, AND RETENTION ANTI-D SERIES 5, LOT 505545. WEAK TO MODERATE/STRONG MIXED-FIELD REACTIVITY WAS OBSERVED AT THE IMMEDIATE SPIN PHASE OF TUBE TESTING WITH A VARIETY OF MANUFACTURERS' ANTI-D REAGENTS. A SERVICE CALL WAS PERFORMED ON 8/18/2006. THE FIELD SERVICE ENGINEER MADE ADJUSTMENTS TO THE PROBES, ENGINEER PERFORMED ROUTINE PREVENTIVE MAINTENANCE. THE REPAIRS HAVE RETURNED THE INSTRUMENT TO ITS EXPECTED FUNCTION.

    Description of Event or Problem · 1

    THERE WAS AN RH DISCREPANCY FOR A PRETRANSFUSION SPECIMEN TESTED ON THE GALILEO. THE SPECIMEN TESTED AS O, RH NEGATIVE ON THE GALILEO. THE SPECIMEN TESTED AS O, RH POSITIVE WITH THE TUBE METHOD. REPEAT TESTING WAS PERFORMED ON GALILEO USING NEW REAGENTS OF THE SAME LOT AS USED FOR THE INITIAL GALILEO TESTING; RESULT WAS O, RH NEGATIVE. NO MEDICAL ACTION WAS TAKEN AS A RESULT OF THE UNEXPECTED NEGATIVE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO KSZ KSZ IMMUCOR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *