BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2001429 · Received February 25, 2011

    Report

    Report Number
    1034569-2011-00020
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 23, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RESULTS: CRRS LOT R128 CELL 2 IS POSITIVE FOR (B)(6). THE ECHO GENERATED NEGATIVE RESULTS FOR ALL CELLS. CELL 2: VISUALLY APPEARED POSITIVE. POS CTRL: 4+. THIS ISSUE WAS COMMUNICATED TO CUSTOMERS IN CC-09-042-02 ON NOVEMBER 25, 2009. THE CUSTOMER WAS ADVISED TO CONTINUE VISUAL REVIEW OF NEGATIVE WELL INTERPRETATIONS FOR CAPTURE R READY-SCREEN OR CAPTURE R READY ID ASSAYS PER CC-09-042-02.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTION WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY SCREEN (CRRS) I AND II ON THE GALILEO ECHO INSTRUMENT. CELLS I AND II RESULTED NEGATIVE. VISUALLY CELL 2 APPEARED POSITIVE. THE CRRS WAS REPEATED AND A POSITIVE RESULT WERE GENERATED FOR CELL 2. NO MANUAL TESTING WAS PERFORMED ON THE SAMPLE.

    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 81 YR