BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2190017 · Received August 4, 2011

    Report

    Report Number
    2122870-2011-02668
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    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

    PATIENT SAMPLE WAS LITHIUM HEPARIN PLASMA IN 13X100 GREINER VACUETTE PRIMARY TUBE. THE SAMPLE WAS CENTRIFUGED AT 3000 G FOR 15 MINUTES AT 19 DEGREES C. PER THE CUSTOMER, THE CUSTOMER NOTED THAT IT WAS A FULL SAMPLE AND THE APPEARANCE WAS CLEAR. PER THE CUSTOMER, THE INSTRUMENT PASSED A HIGH SENSITIVITY SYSTEM CHECK. A CARRYOVER TEST PERFORMED ON (B)(4) 2011 ALSO PASSED. THE CUSTOMER DID NOT PROVIDE SPECIFIC QC NOR SYSTEM CHECK DATA. ON (B)(4) 2011, A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE CLEANED BOTH PRECISION PUMPS, REPLACED BOTH O-RINGS TO IMPROVE SEAL, AND VERIFIED ULTRASONICS AND ALIGNMENTS FOR BOTH PIPETTORS. A CLEAR ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC (BEC) TO REPORT OBTAINING A FALSE POSITIVE TOTAL BETA HUMAN CHORIONIC GONADOTROPIN (THCG) FOR ONE (1) PATIENT, GENERATED BY A UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM, USED IN CONJUNCTION WITH ACCESS THCG REAGENT (LOT 018462) AND ACCESS THCG CALIBRATORS (LOT 014414). REPEAT TESTING OF THE SAMPLE ON THE SAME INSTRUMENT GENERATED A NEGATIVE RESULT, WHICH WAS REPORTED OUT OF THE LAB. 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 600 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXI 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1