BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2142192 · Received May 26, 2011

    Report

    Report Number
    2122870-2011-01152
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    November 21, 2008
    Report Date
    November 21, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE ON (B)(4) 2008. FSE RAN SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK AND BOTH WERE WITHIN SPECIFICATIONS. FSE RAN 10 REPLICATE PRECISION RUNS ON 15 PATIENTS; ALL RESULTS WERE WITHIN ASSAY SPECIFICATIONS. INSTRUMENT VERIFIED AS PERFORMING TO SPECIFICATIONS. THIS IS A SINGLE EVENT INVOLVING MULTIPLE PATIENT SAMPLES. THERE WERE NO REPORTS OF ANY ADVERSE EVENT, CHANGES TO PATIENT CARE OR ANY INDICATION THAT MEDICAL INTERVENTION WAS NEEDED TO PREVENT OR PRECLUDE ADVERSE EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 THRU OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) ON (B)(6) 2008 IN REGARDS TO ERRONEOUS RESULTS OBTAINED FROM A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TROPONIN. TWO PATIENT SAMPLES WERE SUSPECT. THE INITIAL TROPONIN RESULTS WERE ELEVATED. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE NEGATIVE. THE INITIAL ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCE OR CHANGE TO THE PATIENT'S TREATMENT. THERE ARE NO INDICATIONS OF ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PATIENT EVENT.

    Additional Manufacturer Narrative · 2

    FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE ON (B)(4) 2008. FSE RAN SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK AND BOTH WERE WITHIN SPECIFICATIONS. FSE RAN 10 REPLICATE PRECISION RUNS ON 15 PATIENTS; ALL RESULTS WERE WITHIN ASSAY SPECIFICATIONS. INSTRUMENT VERIFIED AS PERFORMING TO SPECIFICATIONS. THIS IS A SINGLE EVENT INVOLVING MULTIPLE PATIENT SAMPLES. THERE WERE NO REPORTS OF ANY ADVERSE EVENT, CHANGES TO PATIENT CARE OR ANY INDICATION THAT MEDICAL INTERVENTION WAS NEEDED TO PREVENT OR PRECLUDE ADVERSE EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 THRU OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 2

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) ON (B)(6) 2008 IN REGARDS TO ERRONEOUS RESULTS OBTAINED FROM A UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM FOR TROPONIN. TWO PATIENT SAMPLES WERE SUSPECT. THE INITIAL TROPONIN RESULTS WERE ELEVATED. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE NEGATIVE. THE INITIAL ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCE OR CHANGE TO THE PATIENTS' TREATMENT. THERE ARE NO INDICATIONS OF ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PATIENT EVENT.

    Additional Manufacturer Narrative · 3

    FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE ON (B)(4) 2008. FSE RAN SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK AND BOTH WERE WITHIN SPECIFICATIONS. FSE RAN 10 REPLICATE PRECISION RUNS ON 15 PATIENTS; ALL RESULTS WERE WITHIN ASSAY SPECIFICATIONS. INSTRUMENT VERIFIED AS PERFORMING TO SPECIFICATIONS. THIS IS A SINGLE EVENT INVOLVING MULTIPLE PATIENT SAMPLES. THERE WERE NO REPORTS OF ANY ADVERSE EVENT, CHANGES TO PATIENT CARE OR ANY INDICATION THAT MEDICAL INTERVENTION WAS NEEDED TO PREVENT OR PRECLUDE ADVERSE EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 THRU OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 3

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) ON (B)(6) 2008 IN REGARDS TO ERRONEOUS RESULTS OBTAINED FROM A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TROPONIN. TWO PATIENT SAMPLES WERE SUSPECT. THE INITIAL TROPONIN RESULTS WERE ELEVATED. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE NEGATIVE. THE INITIAL ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCE OR CHANGE TO THE PATIENT'S TREATMENT. THERE ARE NO INDICATIONS OF ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PATIENT EVENT.

    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
    2 UNK ACCESS ACCUTNI
    3 UNK ACCESS ACCUTNI