BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 1961967 · Received January 15, 2011

    Report

    Report Number
    2122870-2011-00063
    Event Type
    Malfunction
    Date Received
    January 15, 2011
    Date of Event
    December 19, 2010
    Report Date
    December 19, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A GREINER SERUM TUBE WITH GEL, AND SPUN AT 3000 G FOR 10 MINUTES. AFTER THE INITIAL RESULT WAS QUESTIONED BY THE PHYSICIAN, THE SAMPLE WAS INSPECTED AND NOTED TO BE TURBID WITH 2++ HEMOLYSIS. A BLOOD CLOT WAS ALSO NOTED THROUGH THE GEL SEPARATION LAYER OF THE TUBE. THE ALIQOUT ALSO HAD A DEPOSIT FORMED ON THE BOTTOM OF THE TUBE AFTER RE-CENTRIFUGATION. FIVE REPLICATE PRECISION TESTS WERE PERFORMED ON (B)(6) 2010. ALL RESULTS WERE WITHIN THE SPECIFICATIONS. A SYSTEM CHECK DATED (B)(6) 2010 SHOWS ALL RESULTS WITHIN THE PUBLISHED SPECIFICATIONS. THERE IS NO INDICATION THAT SERVICE WAS DISPATCHED FOR THIS EVENT. THE POOR SAMPLE QUALITY IS THE LIKELY ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE GENERATED BY UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED A RESULT WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1