BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1059853 · Received June 10, 2008

    Report

    Report Number
    2122870-2008-00184
    Event Type
    Other
    Date Received
    June 10, 2008
    Date of Event
    May 16, 2008
    Report Date
    June 10, 2008
    Manufacturer
    BECMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COLLECTS SAMPLES IN BD PST TUBES AND CENTRIFUGES SAMPLES IN THE POWER PROCESSOR VIA AN AUTOMATION LINE. QC WAS CURRENTLY PERFORMING WITHIN SPECIFICATIONS AT THE TIME CUSTOMER TECHNICAL SERVICE (CTS) WAS CONTACTED. QC RECOVERED WITHIN RANGE PRIOR TO AND AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE IN 2008: THE FSE FOUND SALT BUILD-UP ON SAMPLE PUMP VALVE. THE FSE REPLACED SAMPLE PUMP. THE FSE PERFORMED DIAGNOSTIC TESTING WHICH PASSED. PERFORMED PRECISION TESTING USING THE LOW LEVEL QC WHICH MET SPECIFICATIONS. THE CUSTOMER RE-SPINS THE SAMPLES PRIOR TO REPEAT ANALYSIS AND THE CUSTOMER WAS WORKING WITH THE SITES BIOMEDICAL ENGINEER TO ADDRESS THEIR CENTRIFUGE PROCESS. A CLEAR ROOT CAUSE OF 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 SEVERAL PATIENTS. CUSTOMER TESTED SEVERAL PATIENT SAMPLES FOR ACCUTNI AND OBTAINED ERRONEOUSLY ELEVATED RESULTS WHICH REPEATED AND RECOVERED IN THE NORMAL RANGE. CUSTOMER HAS NOT SUPPLIED EXACT PATIENT RESULTS TO DATE. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT REPORT PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT 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 BECMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA