BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 3062654 · Received April 17, 2013

    Report

    Report Number
    1034569-2013-00059
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 17, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COLOR CHECK IMAGES SHOWED THAT SEVERAL TEST WELLS CONTAINED BUBBLES. THE CUSTOMER WAS MADE AWARE OF TECHNICAL COMMUNICATION (B)(4) REGARDING LIQUID LEVEL DETECTION AND THAT THE PRESENCE OF BUBBLES MAY CAUSE THE SAMPLE TO BE PIPETTED INCORRECTLY LEADING TO UNEXPECTED NEGATIVE INTERPRETATIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN UNEXPECTED NEGATIVE RESULT WAS OBTAINED ON GALILEO ECHO (B)(4) WITH A SAMPLE KNOWN TO CONTAIN ANTI-K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166109 GALILEO ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR