BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2160260 · Received June 2, 2011

    Report

    Report Number
    2122870-2011-01680
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    October 24, 2008
    Report Date
    October 23, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT REQUEST SERVICE VERIFICATION FOR THIS EVENT. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT. THIS IS FOUR OF FOUR SEPARATE MDR REPORTS RELATED TO FOUR PATIENT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT ON DIFFERENT DAYS. REFERENCE MDR NUMBERS: 2122870-2011-01593, 2122870-2011-01678, 2122870-2011-01679 FOR ALL EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) ON (B)(6) 2008, IN REGARD TO ELEVATED ACCUTNI RESULTS GENERATED ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR 4 PATIENT SAMPLES ON DIFFERENT DAYS. THE INITIAL ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER RE-RAN THE SAMPLES AND THE RESULTS WERE WITHIN NORMAL REFERENCE RANGE. THE CORRECTED RESULTS WERE REPORTED. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCE OR CHANGE TO THE PATIENTS' TREATMENT. THERE ARE NO INDICATIONS OF 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 UNK ACCESS ACCUTNI