BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1556937 · Received December 10, 2009

    Report

    Report Number
    2122870-2009-00378
    Event Type
    Malfunction
    Date Received
    December 10, 2009
    Date of Event
    November 25, 2009
    Report Date
    December 10, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MXZ
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED AT A (B)(4) CLINIC IN A SST TUBE AND CENTRIFUGED AT 3,000 RPM FOR 5 MINUTES. THE SAMPLE WAS THEN TRANSPORTED TO (B)(4) LABS AND TESTED ON THE DXI 800 ANALYZER. THE SPECIMEN WAS NOT ALIQUOTED OR RE-CENTRIFUGED PRIOR TO ANALYSIS. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT. CUSTOMER DID NOT QUESTION ANY OTHER RESULTS OR ASSAYS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE PERFORMED HARDWARE VERIFICATION. ALL VERIFICATION TESTING MET SPECIFICATIONS. NO HARDWARE ISSUES WERE NOTED. PER FSE, THE SAMPLE IN QUESTION HAD A NORMAL APPEARANCE; NO VISIBLE FIBRIN, HEMOLYSIS OR LIPEMIA WERE NOTED. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED LOWER THAN EXPECTED RESULTS FOR PROGESTERONE ON ONE PATIENT'S SAMPLE. THE RESULT WAS REPORTED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN. UPON REPEAT HIGHER RESULTS WERE OBTAINED WITHIN A DIFFERENT CLINICAL RANGE. THE CUSTOMER STATED IT WAS POSSIBLE THAT THE PATIENT RECEIVED PROGESTERONE THERAPY AS A RESULT OF THIS ERRONEOUS RESULT. THE CUSTOMER DID NOT HAVE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MXZ BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1