BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2270150 · Received September 30, 2011

    Report

    Report Number
    1034569-2011-00152
    Event Type
    Malfunction
    Date Received
    September 30, 2011
    Date of Event
    September 2, 2011
    Report Date
    September 29, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEWED THE RETRIEVED INFORMATION: CRRID EXTEND 1 PANEL (B)(4) EXP 25AUG2011 PERFORMED ON (B)(6) 2011 ON (B)(4), CELLS 1-7 ON DP049 ARE C AND E POSITIVE ALL CELLS NEGATIVE, POSITIVE AND NEGATIVE CONTROL AS EXPECTED. WELL IMAGES APPEAR NEGATIVE. BATCH 7193 CAPTURE-R-READY SCREEN 3 (CRRS3) R166, CRRIC 221705 EXP 08SEP2011 PERFORMED ON (B)(6) 2011 ON ECHO INSTRUMENT (B)(4) RESULTED AS NEGATIVE. SCREENING CELL 1 (C AND E POS) SCREENING CELL 2 (C AND E NEG) AND SCREENING CELL 3 (E POS), POSITIVE CONTROL AS EXPECTED. WELL IMAGES APPEAR NEGATIVE. BATCH 8703 (B)(4) EXP 08SEP2011 PERFORMED ON (B)(6) 2011 ON ECHO INSTRUMENT (B)(4) RESULTED AS NEGATIVE. SCREENING CELL 1 (C AND E POS) SCREENING CELL 2 (C AND E NEG) AND SCREENING CELL 3 (E POS), POSITIVE CONTROL AS EXPECTED. WELL IMAGES APPEAR NEGATIVE. BATCH 8704 (B)(4) EXP 08SEP2011 PERFORMED ON (B)(6) 2011 ON ECHO (B)(4) RESULTED AS NEGATIVE. CELLS 1-7 (C AND E POS) RESULTED AS NEGATIVE. CELLS 8-14 RESULTED AS NEGATIVE POSITIVE AND NEGATIVE CONTROL AS EXPECTED. WELL IMAGES APPEAR NEGATIVE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY ID (CRRID) WHEN TESTING A PATIENT SAMPLE ON THE ECHO INSTRUMENT. PATIENT SAMPLE HAS AN ANTI-C AND ANTI-E AS IDENTIFIED BY MANUAL TUBE LISS METHOD WITH 2+TO 3+ REACTIONS.

    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 79 YR