BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1104944 · Received August 7, 2008

    Report

    Report Number
    2122870-2008-00241
    Event Type
    Other
    Date Received
    August 7, 2008
    Date of Event
    July 9, 2008
    Report Date
    August 7, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN GREEN TOP TUBES. THE INSTRUMENT WAS PERFORMING WITHIN QC SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE IN 2008: FSE PERFORMED A SYSTEM CHECK AND PRECISION AND CARRYOVER TESTING. FSE NOTED NO INSTRUMENT PROBLEMS WERE FOUND. THE CUSTOMER CONTACTED CTS (CUSTOMER TECHNICAL SERVICE) THREE DAYS LATER, REQUESTING PRE-ANALYTICAL SAMPLE HANDLING INFO WHICH WAS SENT. FOUR DAYS LATER, CTS CONTACTED THE CUSTOMER TO FOLLOW-UP ON THE EVENT AND THE CUSTOMER REPORTED NO FURTHER INCIDENTS AND THAT THE INSTRUMENT WAS RUNNING WELL. A CLEAR 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 CONTACTED BECKMAN COULTER INC (BCI) REGARDING ERRONEOUSLY ELEVATED ACCUTNI RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PT. CUSTOMER TESTED A PT SAMPLE FOR ACCUTNI AND OBTAINED A RESULT OF 1.06NG/ML AND IT REPEATED AT 0.45NG/ML. ANOTHER SAMPLE WAS OBTAINED FROM THIS PT AND TESTED FOR ACCUTNI AND IT GAVE A RESULT OF 2.22NG/ML AND A REPEAT RESULT OF 0.14NG/ML. ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT REPORT PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA