BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2920404 · Received January 17, 2013

    Report

    Report Number
    1034569-2013-00024
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    November 24, 2012
    Report Date
    January 17, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMAGE RESULT FILES SHOWED THAT NO ERRORS OCCURRED DURING TESTING. INITIAL TESTING WITH THE PRE-TRANSFUSION SAMPLE RESULTED AS NEGATIVE. CELL 1 (K+K+) VISUALLY APPEARED POSITIVE. THE CUSTOMER DID NOT SUBMIT ANY PRODUCTS OR SAMPLES FOR INVESTIGATION. THE IMMUCOR PRODUCT INVESTIGATION LAB CONFIRMED THE PRESENCE OF THE K ANTIGEN ON RETENTION CAPTURE R READY SCREEN 3 (CRRS3), LOT R258 USING ANTI-K, LOT QC # 1 DILUTED 1:256 AND RETENTION CAPTURE R READY INDICATOR RED CELLS (CRRIRC), LOT 221904. CONTROLS PERFORMED AS EXPECTED AND REAGENT RED CELLS TESTED EXHIBITED THE EXPECTED REACTIVITY. RETENTION PRODUCTS PERFORMED AS EXPECTED. CUSTOMERS WERE MADE AWARE OF TECHNICAL COMMUNICATION (B)(4) WHICH ADVISES CUSTOMERS TO VISUALLY INSPECT ALL NEGATIVE ANTIBODY SCREENING AND IDENTIFICATION RESULTS ON THE ECHO PRIOR TO RELEASE OF RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE REACTIVITY WAS OBTAINED WITH CAPTURE-R READY-SCREEN (3) TEST WELLS ON THE ECHO INSTRUMENT ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26062 GALILEO ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR