BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2019977 · Received March 16, 2011

    Report

    Report Number
    1034569-2011-00030
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    March 15, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF IMAGES SHOWS FORWARD ABO AND RH ASSAY FAILURE. A SERVICE CALL WAS MADE. PERFORMED UNEXPECTED REACTIONS CHECKLIST - ALL WITHIN SPECIFICATIONS. PERFORMED GROUP/SCREEN QC - GROUP FAILED. INVESTIGATION REVEALED DI WATER CUBE HAD INADVERTENTLY BEEN USED TO FILL SALINE. CONTAINER ON INSTRUMENT CAUSING HEMOLYSIS IN ABO/RH RESULTS PRIMED INSTRUMENT WITH SALINE AND RERAN GROUP/SCREEN QC WITH EXPECTED RESULTS. INSTRUMENT NOW PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN RH DISCREPANCY ON THE ECHO. A SAMPLE PREVIOUSLY REPORTED AS O POS BY MANUAL TESTING WAS TESTED ON THE ECHO AND CAME UP AS O NEG. RE-TESTING BY MANUAL TUBE METHOD RESULTED AS O POS.

    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