BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1066978 · Received June 27, 2008

    Report

    Report Number
    2122870-2008-00210
    Event Type
    Malfunction
    Date Received
    June 27, 2008
    Date of Event
    June 8, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SERUM. PER CUSTOMER, THE SAMPLE APPEARED NORMAL AND WAS PROCESSED ON THE AUTOMATION LINE. A SYSTEM CHECK PERFORMED IN 2008 PASSED WITHIN SPECIFICATIONS. NO ERRORS WERE POSTED TO THE EVENT LOG, AND THE RESULT WAS NOT FLAGGED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE PERFORMED ALIGNMENTS ON DISPENSE AND ASPIRATE PROBE PLATES AND SERVICED THE SUBSTRATE PROBE WHICH WAS LOOSE. THE SYSTEM CHECK PASSED, BUT PRECISION RUN FAILED. THE FSE REPLACED HARDWARE COMPONENTS AND PERFORMED ALIGNMENTS AGAIN AND THEN PERFORMED A DIAGNOSTIC TESTING AND SOME PARAMETERS FAILED. THE FSE REPLACED PERI TUBING AND DISPENSE PROBES AND THEN FAILED PARAMETERS OF THE DIAGNOSTIC TESTING PASSED, BUT THE PRECISION TEST FAILED ON REAGENT PIPETTOR #2. THE FSE REPLACED SEVERAL HARDWARE COMPONENTS AND CLEANED WASH PUMP VALVES AND THE PRECISION RUN FAILED AGAIN. THE FSE ADJUSTED ALIGNMENT ON THE REAGENT PIPETTOR #2, THEN THE PRECISION RUN AND ALL OTHER VERIFICATION TESTING PASSED. HARDWARE ISSUES ADDRESSED BY THE FSE MAY HAVE CONTRIBUTED TO THIS EVENT; HOWEVER, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. 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 AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT GENERATED BY THE ACCESS 2 INSTRUMENT FOR A SINGLE PT SAMPLE. THE INITIAL ACCU TNI RESULT WAS 0.52NG/ML. THE ORIGINAL SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND AN ACCU TNI RESULT OF 0.12NG/ML WAS OBTAINED. THERE HAS BEEN NO REPORT OF DEATH, INJURY, OR CHANGE TO PT TREATMENT IN ASSOCIATION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA