BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2073405 · Received May 1, 2011

    Report

    Report Number
    2122870-2011-01232
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    March 9, 2009
    Report Date
    March 12, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    Z-1318-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE COLLECTION AND CENTRIFUGATION DATA WAS SUPPLIED. CUSTOMER REPORTED TO BCI CTS (CUSTOMER TECHNICAL SUPPORT) THAT A NOTICEABLE DIFFERENCE IN TROPONIN (ACCUTNI) PATIENT RESULTS BETWEEN THE 2 INSTRUMENTS AROUND THE TIME THAT ACCUTNI REAGENT LOT NUMBER 850003 WAS PUT INTO USE. ACCUTNI REAGENT LOT NUMBER 850003 WAS IN USE ON THE DXI WHEN PATIENT ONE WAS PROCESSED. ACCUTNI REAGENT LOT NUMBER 850010 WAS IN USE ON THE DXI WHEN PATIENT TWO WAS PROCESSED. TWO LEVELS OF ACCUTNI QC RESULTED WITHIN SPECIFICATIONS ON (B)(6) 2009. A SYSTEM CHECK PERFORMED ON (B)(6) 2009 AT 11:52 RESULTED WITHIN SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) PERFORMED A PREVENTIVE MAINTENANCE (PM) THE WEEK OF (B)(6) 2009. FSE 20-REPLICATE PRECISION RUN WITH GOOD PRECISION BETWEEN PIPETTORS 1 AND 2. FSE PERFORMED HIGH-SENSITIVITY SYSTEM CHECK. RESULTS RECOVERED WITHIN 1 SD OF THE SAME 7 PATIENT RESULTS FROM THE OTHER INSTRUMENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 - OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ELEVATED TROPONIN (ACCUTNI) RESULTS GENERATED BY THE UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM. THE TWO SAMPLES WERE REPEATED ON AN ALTERNATE ANALYZER AND RESULTS IN THE NORMAL REFERENCE RANGE WERE OBTAINED. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1