BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2297249 · Received October 15, 2011

    Report

    Report Number
    2122870-2011-04612
    Event Type
    Malfunction
    Date Received
    October 15, 2011
    Date of Event
    August 30, 2011
    Report Date
    September 14, 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
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS SERUM IN GEL SEPARATOR TUBE, CENTRIFUGED FOR 10 MINUTES AT 3000 RPMS. SYSTEM CHECK DATA WAS WITHIN SPECIFICATIONS. THE CUSTOMER HAD CALIBRATED ON THIS DAY. QUALITY CONTROL WAS RUN AFTER CALIBRATION AND RECOVERED WITHIN THE CUSTOMER'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, NO DEFINITIVE ROOT CAUSE WAS DETERMINED FOR THE EVENT. THE FSE PERFORMED A TEN REPLICATE PRECISION RUN USING THE CUSTOMER'S LEVEL 1 AND 3 QC, WHICH RECOVERED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING AN ELEVATED FREE THYROXINE (T4) RESULT ABOVE THE CUSTOMER'S REFERENCE RANGE FOR ONE (1) PATIENT. THE RESULT WAS GENERATED ON AN ACCESS 2 IMMUNOASSAY ANALYZER, USED IN CONJUNCTION WITH ACCESS FREE T4 REAGENT (LOT 111453) AND ACCESS FREE T4 CALIBRATORS (LOT 109605). THE RESULT WAS REPORTED OUT OF THE LABORATORY AND WAS QUESTIONED BY THE PHYSICIAN. REPEAT ANALYSIS OF THE SAMPLE ON THE SAME INSTRUMENT REPRODUCED THE ELEVATED RESULT. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND ANALYZED ON AN IMMULITE. THE RESULT WAS WITHIN THE CUSTOMER'S NORMAL REFERENCE RANGE. THE PHYSICIAN HAD QUESTIONED ANOTHER PATIENT'S FRT4 RESULTS. HOWEVER, THE PHYSICIAN DID NOT PROVIDE ANY INFORMATION TO THE LABORATORY AND NO REPEAT TESTING WAS PERFORMED ON THIS PATIENT'S SAMPLE. NO CHANGE IN TREATMENT OR INJURY TO PATIENT WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1