BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1239824 · Received November 24, 2008

    Report

    Report Number
    1034569-2008-00574
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    November 20, 2008
    Report Date
    November 24, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBABILITY OF OCCURRENCE IS RARE SINCE THE ISSUE WILL ONLY OCCUR IF A CLOT DETECTION IS TRIGGERED. THE CONTINUED MOTION OF THE PROBE FOLLOWING RECEIPT OF THE ERROR INTRODUCES THE POSSIBILITY THAT THE CLOT COULD BE DRAGGED ACROSS OTHER SAMPLE TUBES AS THE PROBE MOVES. THIS HAS THE POTENTIAL TO CONTAMINATE OTHER SAMPLES WITH NO WARNING TO THE USER. ECHO SOFTWARE SP2 PATCH 1 WAS ISSUED TO CUSTOMERS TO CORRECT THE ANOMALY.

    Description of Event or Problem · 1

    WHILE PERFORMING A REFLEX GROUP SCREEN, A CLOT DETECTED ERROR WAS GENERATED. BEFORE CONTINUE PROCESSING COULD BE SELECTED, IT APPEARED AS IF THE PROBE MOVED TO THE RINSE STATION AND THE RINSE STEP WAS IN PROGRESS. THE PROBE SHOULD NOT HAVE BEGAN RINSING PRIOR TO "CONTINUE PROCESSING" BEING SELECTED, AND THE ERROR SHOULD NOT HAVE OCCURRED AFTER SELECTING "CONTINUE PROCESSING".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1