BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2662107 · Received July 19, 2012

    Report

    Report Number
    1034569-2012-00139
    Event Type
    Malfunction
    Date Received
    July 19, 2012
    Date of Event
    June 19, 2012
    Report Date
    July 19, 2012
    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

    AN IMMUCOR TECHNICAL SUPPORT SPECIALIST REVIEWED THE IMAGE RESULT FILES AND FOUND THAT THE INITIAL REFLEX GROUP INTERPRETED AS WEAK D PENDING, BUT THE WEAK D WAS INTERPRETED AS POSITIVE DUE TO A BUBBLE BEING PIPETTED INTO THE WELL. THE CUSTOMER WAS INFORMED THAT THE SAMPLE HAD BEEN TESTED AS A REFLEX GROUP AND WAS INTERPRETED AS A WEAK D PENDING IN BATCH 32. THE WEAK D WAS THEN PERFORMED IN BATCH 36 AND DUE TO THE BUBBLE THAT WAS PIPETTED WAS INTERPRETED AS POSITIVE, CAUSING THE INTERPRETATION OF THE GROUP TO BE UPDATED TO A RH POSITIVE. THE SAMPLE WAS REPEATED FOR THE REFLEX GROUP IN BATCH 38 AND THE WEAK D WAS PERFORMED IN BATCH 39. THE WEAK D FROM BATCH 39 INTERPRETED AS NEGATIVE AND WAS VISUALLY NEGATIVE. THESE LATER RESULTS DIDN'T OVERRIDE THE PREVIOUS RESULTS AS THE SOFTWARE DOESN'T ALLOW FOR THIS. REPEAT TESTING ON THE SAMPLE IN BATCHES 38 AND 39 DID INTERPRET AS EXPECTED FOR BOTH THE REFLEX GROUP AND THE WEAK D INTERPRETING AS NEGATIVE AS EXPECTED ON THE DONOR SAMPLE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A KNOWN DONOR, WHO IS TYPE A, RH NEGATIVE WAS INTERPRETED AS TYPE A, RH POSITIVE ON THE GALILEO ECHO (B)(4).

    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