BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1167446 · Received September 23, 2008

    Report

    Report Number
    1034569-2008-00464
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 22, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE E AND JKA ANTIGENS WAS CONFIRMED ON RETENTION CAPTURE-R READY SCREEN (CRRS)(3), LOT R025 AND RETENTION CRRID, LOT ID104 AND DP029. THESE PRODUCTS WERE USED BY THE CUSTOMER AT THE TIME OF THE COMPLAINT. THE CUSTOMER'S SUBMITTED SAMPLES EXHIBITED 3+ HEMOLYSIS AND WERE NOT TESTED ON AN IN-HOUSE ECHO. MANUAL TESTING WAS PERFORMED WITH RETENTION CRRS(3), LOT R025. MODERATE REACTIVITY WAS OBSERVED WITH E+ AND JK(A+) REAGENT RED CELLS. ADDITIONAL TESTING IN TUBE TESTS WITH PANOSCREEN I, II AND III, USING IMMUADD AS THE POTENTIATOR, SHOWED WEAK REACTIVITY WAS OBSERVED AT 37C AND MODERATE REACIVITY AT THE INDIRECT ANTIGLOBULIN TEST PHASE WITH E+E- REAGENT RED CELLS. THE ANTI-JKA WAS NOT DETECTED IN TUBE TESTING. TESTING WITH RETENTION CRRID AND CRRID EXTEND WAS ALSO PERFORMED. E+, JK(A-) REAGENT RED CELLS EXHIIBITED MODERATE REACTIVITY; E-JK(A+B-) EXHIBITED NO REACTIVITY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON THE ECHO WHEN TESTING WITH CAPTURE-R READY ID (CRRID) AND CAPTURE-R READY ID EXTEND. TWO SAMPLES FROM THE SAME PATIENT APPEARED POSITIVE ON THE ECHO, BUT WERE INTERPRETED AS NEGATIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR