BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABS2000

    MDR report key: 1022984 · Received April 3, 2008

    Report

    Report Number
    1034569-2008-00084
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 20, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK960019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESENCE OF THE K ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY-SCREEN(4), LOT G156. THE TWO SAMPLES RETURNED BY THE CUSTOMER WERE TESTED ON AN IN-HOUSE ABS2000 USING RETENTION CRRS(4), LOT G156, AND RETENTION CAPTURE-R INDICATOR RED CELLS, LOT 221124. BOTH SAMPLES WERE NONREACTIVE. THE TWO CUSTOMER SAMPLES WERE TESTED ON AN IN-HOUSE ECHO INSTRUMENT USING RETENTION CRRS(3), LOT R019. BOTH SAMPLES WERE POSITIVE ON THE ECHO. PERFORMED MANUAL SOLIDPHASE TESTING ON BOTH RETURNED SAMPLES USING RETENTION CRRS(4), LOT G156. THE SAMPLES EXHIBITED POSITIVE REACTIVITY WITH K+K+ REAGENT RED CELLS.THE SAMPLES WERE TESTED IN HEMAGGLUTINATION TESTS USING RETENTION PANOSCREEN I, II AND III, LOT 53436 WITH IMMUADD AS THE POTENTIATOR. A ROOM TEMPERATURE INCUBATION WAS INCLUDED. NO MACROSCOPIC REACTIVITY WAS OBSERVED WITH K+K+ RED CELLS; ONLY MICROSCOPIC REACTIVITY WAS OBSERVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN REACTION ON THE ABS2000. THE PATIENT SAMPLE WAS NEGATIVE ON THE ABS2000 AND BY TUBE METHOD, BUT POSITIVE ON THE ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABS2000 AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR