BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2142170 · Received May 26, 2011

    Report

    Report Number
    2122870-2011-01272
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    December 5, 2008
    Report Date
    December 5, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS ON SITE (B)(4) 2008 TO INVESTIGATE THE EVENT. FSE RAN HIGH SENSITIVITY (HS) SYSTEM CHECK AND OBTAINED FAILURES ON THE FOAM PORTION. THE FSE CHECKED ASPIRATION AND REPLACED PERI-PUMP TUBING. THE FSE FOUND BUILD UP ON THE PERI-PUMP MANIFOLD WHICH WAS CLEANED. FSE CHECKED ASPIRATE PROBE #1 WASH MANIFOLD AND REPLACED THE DUCKBILL VALVE. THE FSE ALSO, CHECKED PICK AND PLACE COLLETS/PISTONS AND FOUND WASH PICK AND PLACE PISTON WITH SIGNIFICANT BUILD-UP. THE BUILD UP WAS CLEANED AND THE HS SYSTEM CHECK WAS REPEATED AND IT PASSED. A 200 REPLICATES VERIFICATION RUN OF ACCUTNI BLANKS WAS PERFORMED BY THE FSE WHICH ALL RESULTED AT 0.0 NG/ML OR NO VALUE. ALSO, THE FSE VERIFIED THE REPAIRS PER ESTABLISHED PROCEDURES, AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. ALTHOUGH THE ROOT CAUSE OF THE EVENT IS UNKNOWN, SAMPLE HANDLING MAY BE A POSSIBLE CONTRIBUTING CAUSE TO THIS EVENT. THIS IS A SINGLE EVENT INVOLVING MULTIPLE PATIENT SAMPLES. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN 01/01/2008 AND 10/23/2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI), REGARDING ERRONEOUSLY HIGH ACCUTNI (TROPONIN) RESULTS GENERATED ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR FOUR PATIENTS. THE CUSTOMER LABORATORY HAS A REPEAT RESULT POLICY AND PATIENTS SAMPLES WERE REPEATED ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN RANGE SPECIFICATION. THE INITIAL ERRONEOUSLY HIGH ACCUTNI RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCES OR CHANGE TO THE PATIENTS' TREATMENT. THERE ARE NO INDICATIONS OF ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PATIENT EVENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI