BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 1935892 · Received December 22, 2010

    Report

    Report Number
    1034569-2010-00265
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    October 13, 2010
    Report Date
    December 22, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE ECHO INSTRUMENT EVENT LOG FROM (B)(6) 2010 SHOWED THAT A SAMPLE RACK WAS LOADED TWICE IN POSITION 3 ON THE SAMPLE LOADING BAY AND THE SAMPLE ID'S IN POSITIONS 1 AND 2 WERE NOW READING AS POSITIONS 4 AND 5. SAMPLES THAT WERE ORIGINALLY IN POSITIONS 4 AND 5 WERE READING AS POSITIONS 1 AND 2. A REVIEW OF THE FAXED BATCH REPORT SHOWED THE ABO MISTYPES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. ROOT CAUSE IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    SAMPLE ID'S (AND REPORTED RESULTS) SWITCHED WITHIN SINGLE REAGENT RACK ON ECHO INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1