BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2183543 · Received July 8, 2011

    Report

    Report Number
    2122870-2011-01178
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    January 29, 2009
    Report Date
    January 29, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL (QC) WAS WITHIN SPECIFICATIONS PRIOR TO THE ERRONEOUS RESULT. LEVEL 3 QC TESTED ON (B)(6) 2009 AT 13:53 WAS OUT OF THE CUSTOMER'S SPECIFICATIONS. LEVEL 1 AND 2 QC WERE WITHIN SPECIFICATIONS. NO ERRORS WERE POSTED TO THE EVENT LOG. FIELD SERVICE ENGINEER EVALUATED THE ANALYZER ON (B)(4) 2009. HARDWARE VERIFICATION TESTING PASSED PUBLISHED SPECIFICATIONS. THERE WERE NO HARDWARE ISSUES. ROOT CAUSE WAS NOT DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ERRONEOUS VITAMIN B12 TEST RESULT ABOVE THE NORMAL REFERENCE RANGE WAS OBTAINED FOR ONE PATIENT WHEN USING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE ERRONEOUS TEST RESULT WAS IDENTIFIED WHEN COMPARED TO A SECOND TEST VITAMIN B12 TEST RESULT THAT WAS WITHIN THE NORMAL REFERENCE RANGE. ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. A CORRECTED REPORT WAS SENT TO THE PHYSICIAN. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR ACCESS VITAMIN B12 ASSAY