BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 2833342 · Received November 15, 2012

    Report

    Report Number
    1034569-2012-00211
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 12, 2012
    Report Date
    November 14, 2012
    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

    UNABLE TO VIEW RESULT IMAGE FILES AS CUSTOMER DOES NOT ARCHIVE IMAGES AND THEY ARE NOT AVAILABLE IN ARCHIVE DATABASE. THE REACTION STRENGTHS WERE REVIEWED AND ANTI-B WAS GRADED AS 1+ ON GALILEO, REACTION STRENGTH OF 40; CUT-OFF FOR NEGATIVE REACTION IS 0-34. REVERSE B TYPE WAS APPROACHING THRESHOLD OF NTD (NO TYPE DETERMINED); CUT-OFF FOR NEGATIVE IS 0-22. UNABLE TO RULE OUT SAMPLE. THE CUSTOMER PROVIDED THREE TUBES OF THE SAMPLE FOR INVESTIGATION. IMMUCOR'S PRODUCT INVESTIGATIONS LAB PERFORMED AN ABO_RH ASSAY ON KNOWN ABO IN-HOUSE DONORS ON THE GALILEO USING RETENTION ANTI-B, LOT 203382. ALL DONORS RESULTED AS EXPECTED. HEMAGGLUTINATION TESTING WAS PERFORMED ON RETENTION A1 REFERENCELLS, LOT 111891, A2 REFERENCELLS, LOT 112685, B REFERENCELLS, LOT 113891, AND O REFERENCELLS, LOT 114184 WITH RETENTION ANTI-B, LOT 203382. ALL RETENTION PRODUCTS PERFORMED AS EXPECTED. AN ABO_RH ASSAY WAS PERFORMED ON THE CUSTOMERS SUBMITTED SAMPLE ON THE GALILEO AND IN TUBES USING RETENTION ANTI-B, LOT 203382. NO UNEXPECTED REACTIVITY WITH ANTI-B, LOT 203382, WAS OBSERVED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY. THE PRODUCT IS PERFORMING ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN ABO MISTYPE OCCURRED WITH A KNOWN TYPE A POSITIVE SAMPLE THAT TYPED AS AB POSITIVE WITH ANTI-B (MURINE MONOCLONAL) SERIES 3, LOT 203382, ON THE GALILEO.

    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