BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2030073 · Received March 25, 2011

    Report

    Report Number
    2122870-2011-00809
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A CORVAC TUBE THAT CONTAINED A GEL SEPARATOR. CUSTOMER NOTED THAT SAMPLE WAS NORMAL IN APPEARANCE THE SAMPLE FROM (B)(6) 2011 WAS REFRIGERATED AND RE-RAN ON (B)(6) 2011. THE CUSTOMER STATED THAT MAY BE THE REASON THE LAST RESULT WAS SO LOW. CUSTOMER RUNS 3 LEVELS OF FT4 QC ON A DAILY BASIS. ALL FT4 QC PASSED WITHIN THE ESTABLISHED RANGES ON ALL DAYS ASSOCIATED WITH THIS EVENT, BUT A LITTLE ON THE LOW SIDE. BCI CUSTOMER TECHNICAL SUPPORT (CTS) NOTED THE CALIBRATION WAS RECOVERING ABOUT HALF OF WHAT IN HOUSE DATA FOUND FOR RLUS FOR ALL STANDARDS. THE CTS SENT CUSTOMER ANOTHER LOT OF CALIBRATOR AND QC MATERIAL. THE CTS ALSO ADVISED TO CHANGE REFERENCE RANGES BACK TO INSERT RANGES BECAUSE THE CUSTOMER WAS UNABLE TO IDENTIFY WHERE HER RANGES CAME FROM. CUSTOMER HAD RECALIBRATED AND RAN QC; CUSTOMER ALSO RERAN OLD SURVEY SAMPLES AND PATIENT SAMPLES. CUSTOMER NOTED THE RESULTS WERE COMPARABLE WITHIN RANGE. SERVICE WAS NOT DISPATCHED AS CUSTOMER WAS NOT QUESTIONING THE FUNCTIONING OF THE INSTRUMENT. NO CLEAR ROOT CAUSE HAS BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A LOW FREE T4 (FT4) RESULT GENERATED ON ACCESS 2 IMMUNOASSAY ANALYZER FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY, AND WAS QUESTIONED BY THE PHYSICIAN. THE RESULT WAS IN DISCORDANCE WITH TWO ALTERNATE METHODOLOGIES. THE RESULTS ARE SHOWN. NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1