BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2190020 · Received August 4, 2011

    Report

    Report Number
    2122870-2011-02673
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 1, 2011
    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

    PATIENT SAMPLE WAS COLLECTED IN A 13X100MM GREINER SERUM TUBE WITH A GEL SEPARATOR AND CENTRIFUGED FOR 10 MINUTES AT 3000G AT 20 DEGREES C. THE CUSTOMER STATED THAT THE SAMPLE WAS A HALF FULL TUBE AND WAS ANALYZED FROM AN ALIQUOT OF THE ORIGINAL SAMPLE. PER THE CUSTOMER, ACCUTNI QC HAD BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGES. SPECIFIC QC DATA WAS NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER DID NOT PROVIDE SYSTEM INFORMATION. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER WAS NOT QUESTIONING INSTRUMENT PERFORMANCE AT THIS TIME. 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 AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE (1) PATIENT. THE ELEVATED ACCUTNI RESULT WAS GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, USED IN CONJUNCTION WITH ACCESS ACCUTNI REAGENT (LOT 110863). SUBSEQUENT TESTING ON THE SAME INSTRUMENT PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE ELEVATED ACCUTNI RESULT WAS NOT 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 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE MMI BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1