BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2960557 · Received February 14, 2013

    Report

    Report Number
    1034569-2013-00033
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 14, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMAGE FILES SHOWED THAT A BUBBLE WAS PRESENT IN THE ANTI-D WELL AND INDICATOR WELL. IT DID NOT APPEAR THAT THE INDICATOR CELLS WERE PIPETTED. ALL OTHER REACTIONS APPEARED AS EXPECTED. THE CUSTOMER PERFORMED THE PROBE ACCURACY TEST. ACCEPTABLE RESULTS WERE OBTAINED. THE CUSTOMER CHECKED THE CONNECTION ON THE BUFFER SUPPLY BOTTLE AND FOUND FRESH SALT CRYSTALS AT THE BUFFER BOTTLE CONNECTION. THE CUSTOMER TIGHTENED THE ENTIRE CONNECTION TO THE BUFFER SUPPLY BOTTLE AND WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN UNEXPECTED POSITIVE RESULT WAS OBTAINED ON THE WEAK D ASSAY ON GALILEO ECHO M01155.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64114 GALILEO ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR