BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2183547 · Received July 8, 2011

    Report

    Report Number
    2122870-2011-01294
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    December 9, 2008
    Report Date
    December 9, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(6) 2008. THE FSE PERFORMED THE HIGH SENSITIVITY (HS) SYSTEM CHECK AND IT FAILED ON PIPETTOR # 2. THE FSE PERFORMED ALIGNMENTS. FSE REPEATED HS SYSTEM CHECK AND RAN CARRYOVER PROCEDURE. BOTH PROCEDURES PASSED WITHIN PUBLISHED SPECIFICATIONS. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN 01/01/2008 THROUGH 10/23/2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS RESULTS ON TROPONIN, CKMB AND MYOGLOBIN ASSAY FOR ONE PATIENT'S SAMPLE WITH MULTIPLE DRAWS. THE PATIENT SAMPLE WAS TESTED ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. A REPEAT OF THE SAMPLE TESTING WAS PERFORMED ON ANOTHER INSTRUMENT AND THE RESULTS WERE WITHIN THE REFERENCE RANGE. THE EVENT LOG SHOWS NO SYSTEM ERRORS OCCURRED AT THE TIME THE PATIENT SPECIMEN WAS PROCESSED. THE INITIAL ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCE OR 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 52 YR ACCESS CK-MB| ACCESS MYOGLOBIN| ACCESS ACCUTNI