BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2627858 · Received June 25, 2012

    Report

    Report Number
    2122870-2012-01519
    Event Type
    Malfunction
    Date Received
    June 25, 2012
    Date of Event
    May 26, 2012
    Report Date
    May 30, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE ISSUE WAS DUE TO CUSTOMER'S USE OF A SHARED REAGENT PACK. THE CTS REVIEWED THE IMPORTANCE OF NOT SHARING PACKS BETWEEN INSTRUMENTS WITH CUSTOMER. CUSTOMER ACKNOWLEDGED THIS INFORMATION AND STATED THAT IT WOULD BE REVIEWED WITH LABORATORY STAFF. CUSTOMER HAS NOT CALLED BACK TO REPORT ANY FURTHER ISSUES RELATING TO THIS EVENT. (B)(4). CUSTOMER DID NOT REQUEST/REQUIRE SERVICE

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM DISPLAYED PACK MONITORING ERRORS. THE CUSTOMER TECHNICAL SPECIALIST (CTS), VIA (B)(4), EVALUATED THE ISSUE AND WAS ABLE TO DETERMINE THAT THE ERRORS OCCURRED ON REAGENT PIPETTORS 3 AND 4 ONLY. THE CTS ALSO NOTED THAT THE ERRORS ONLY OCCURRED ON ONE PARTICULAR FRT4 (FREE THYROXINE) REAGENT PACK. REVIEW OF REAGENT INVENTORIES FROM CUSTOMER'S TWO DXI INSTRUMENTS SHOWED THAT A FRT4 REAGENT PACK (LOT #120126, SERIAL NUMBER (B)(4)) WAS LOADED AND USED ON BOTH INSTRUMENTS. CUSTOMER DID NOT SUPPLY QC (QUALITY CONTROL), CALIBRATION CURVES OR SYSTEM CHECKS FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1