BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2760158 · Received September 26, 2012

    Report

    Report Number
    1034569-2012-00177
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 29, 2012
    Report Date
    September 26, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMAGE RESULT FILES WERE REVIEWED BY AN IMMUCOR TECHNICAL SUPPORT SPECIALIST. CELL 1 OF THE SCREENING ASSAY IS POSITIVE FOR THE K ANTIGEN. THE SAMPLE RESULTED AS NEGATIVE FOR ALL CELLS. ALL CELLS VISUALLY APPEARED NEGATIVE AS REPORTED. CONTROL RESULTED AS EXPECTED. UPON REVIEW OF THE ANTIBODY IDENTIFICATION ASSAY RESULTS, A DIFFERENT SAMPLE (SAME PATIENT) WAS TESTED AND NEGATIVE RESULTS WERE OBTAINED FOR ALL CELLS. CELLS 8, 11 AND 14 (K POSITIVE CELLS) RESULTED AS NEGATIVE AND VISUALLY APPEARED NEGATIVE. THE CUSTOMER WAS ASKED TO REPEAT THE SAMPLE WITH A KNOWN POSITIVE SAMPLE. CELL 1, WHICH IS K POSITIVE, RESULTED AS NEGATIVE AND VISUALLY APPEARED NEGATIVE. CELL 2 RESULTED AS EQUIVOCAL. THE EXPECTED POSITIVE RESULTS WERE OBTAINED WITH THE KNOWN POSITIVE SAMPLE. AN ANTIBODY IDENTIFICATION PANEL WAS PERFORMED WITH A NEWLY DRAWN SAMPLE (SAME PATIENT) AND CELLS 1, 3, 6 AND 14 RESULTED AS POSITIVE (CELLS 8, 11 AND 14 ARE K POSITIVE). RESULTS VISUALLY APPEARED POSITIVE. A NEGATIVE RESULT WAS OBTAINED WITH CELL 8 WHICH VISUALLY APPEARED NEGATIVE. CELL 11 RESULTED AS EQUIVOCAL WITH THE RED CELL BUTTON HAVING A FUZZY APPEARANCE. CONTROLS RESULTED AS EXPECTED. THE UNEXPECTED REACTIVITY APPEARS TO BE SAMPLE RELATED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE RESULTS WERE OBTAINED FOR ONE PATIENT ON THE CAPTURE-R READY ANTIBODY SCREENING AND IDENTIFICATION ASSAYS ON GALILEO ECHO INSTRUMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR