BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1727172 · Received June 17, 2010

    Report

    Report Number
    1034569-2010-00132
    Event Type
    Malfunction
    Date Received
    June 17, 2010
    Date of Event
    May 20, 2010
    Report Date
    June 17, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK 040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RETRIEVED IMAGES: A10- NEGATIVE RESULT/ 12 REACTION STRENGTH- VISUALLY THE WELL IS DARK RED WITH A BLUE OUTLINE. B10- 4+ REACTION/ 99 REACTION STRENGTH- VISUALLY POSITIVE. C10-4+ REACTION/ 98 REACTION STRENGTH- VISUALLY POSITIVE. D10- NEGATIVE REACTION/ 7 REACTION STRENGTH- VISUALLY NEGATIVE. CANNOT RULE OUT SAMPLE AS THE CAUSE OF THE UNEXPECTED RESULT DUE TO THE DARK RED APPEARANCE OF THE ANTI-A WELL. CUSTOMER DID NOT HAVE ANY OTHER SAMPLES WITH THIS ERROR OR APPEARANCE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A NEONATAL SAMPLE THAT WAS TESTED ON THE GALILEO FWD ABO ASSAY AND HAD RESULTED AS B POS. THE SAMPLE WAS TESTED BY MANUAL TUBE METHOD AND RESULTED AS AB POS.

    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 1 DA