BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 2450088 · Received February 14, 2012

    Report

    Report Number
    1034569-2012-00021
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    January 16, 2012
    Report Date
    February 14, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE COURSE OF THE INVESTIGATION IT WAS DETERMINED THAT THE SAMPLE HAD BEEN TESTED ON PLATE (B)(4) AND HAD BEEN INTERPRETED AS REFLEX ABO PENDING RH POSITIVE. WHEN THE SAMPLE WAS THEN RETESTED ON PLATE (B)(4) THE INTERPRETATION WAS OF O RH NEGATIVE, BUT THE ORIGINAL RH OF POSITIVE WAS KEPT BY THE GALILEO AND MERGED WITH THE LATER ABO OF O AND THE FINAL RESULT WAS GIVEN AS O RH POSITIVE. NO WEAK D WAS ORDERED OR PERFORMED ON THE GALILEO. IT WAS FOUND DURING THE INVESTIGATION THAT THE ORIGINAL TESTING PLATE HAD IMAGE ANALYSIS EMPTY OR TOO DENSE WELLS DETECTED FLAGS FOR 11 OF THE 12 SAMPLES. REVIEW OF THE PLATE SHOULD THAT SEVERAL OF THE WELLS WERE MISSING REAGENTS. NO OTHER PLATES WERE AFFECTED BY THIS. REVIEW OF THE LOG LIST DID FIND THAT THE GALILEO DID GIVE PIPETTOR RIGHT Z OR SPREAD ERROR AS WELL AS BAD LLD SIGNAL. THE ISSUE THAT WAS PRESENTED BY THE CUSTOMER IS DOCUMENTED IN THE GALILEO OPERATOR'S MANUAL CHAPTER. THE SOFTWARE OF THE GALILEO IS DESIGNED TO HAVE AN ELEMENT (RESULT) OVERRIDE A NEW RESULT(ELEMENT) IN THE REFELEX ABORH AND REFLEX FWD ASSAY. IN THIS CASE THE ELEMENT WAS THE RH INTERPRETATION FROM THE FIRST PLATE WAS KEPT AS BEING ACCURATE BY THE GALILEO. THE SAMPLE WAS THEN REPEATED AND THE INTERPRETATION ON THE REPEAT PLATE WAS O RH NEG, BUT DUE TO THE EARLY RH POSITIVE INTERPRETATION THE RESULTS MERGED TOGETHER AND THE O RH POSITIVE INTERPRETATION WAS WHAT WAS APPROVED AND EXPORTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN RH DISCREPANCY WHEN TESTING A DONOR SAMPLE ON THE GALILEO. THE SAMPLE WAS TYPED AS O RH PENDING ON THE GALILEO AND THEN THE WEAK D TYPED AS RH POSITIVE. THE DONOR SAMPLE IS HISTORICALLY O RH NEGATIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR