BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 1362916 · Received April 16, 2009

    Report

    Report Number
    2122870-2009-00129
    Event Type
    Malfunction
    Date Received
    April 16, 2009
    Date of Event
    March 27, 2009
    Report Date
    April 16, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN PLASTIC BD LITHIUM HEPARIN PLASMA TUBES WITH GEL SEPARATOR AND CENTRIFUGED AT 3,600 RPMS FOR FIVE MINUTES. SAMPLE OF PATIENT A WAS ALIQUOTED FROM THE PRIMARY TUBE, AND PROCESSED THROUGH THE CLOSED TUBE ACCESSING (CTA) SYSTEM. PER CUSTOMER, THE SAMPLE WAS A "SHORT DRAW". SAMPLE OF PATIENT B WAS ALSO PROCESSED THROUGH THE CTA. QC WAS WITHIN SPECIFICATIONS BEFORE AND AFTER THE EVENT. A SYSTEM CHECK PERFORMED ON (B)(6) 2009 FAILED, AND PASSED ALL PORTIONS WHEN IT WAS REPEATED LATER. A CUSTOMER TECHNICAL SERVICE (CTS) SUGGESTED THAT CUSTOMER DISCONTINUE RUNNING PATIENT SAMPLES UNTIL SERVICE CAN CHECK HARDWARE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE INSPECTED THE INSTRUMENT AND CHECKED SEVERAL HARDWARE COMPONENTS. THE FSE NOTED THAT WASH PUMP HAD A CRACK, WHICH WAS INTRODUCING AIR BUBBLES INTO PUMP; WASH PUMP WAS REPLACED. THE FSE PERFORMED A DIAGNOSTIC TESTING. HARDWARE VERIFICATION TESTING PASSED. HARDWARE ISSUE ADDRESSED BY THE FSE MAY HAVE CONTRIBUTED TO THIS EVENT. 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 TROPONIN (ACCU TNI) RESULTS THAT WERE GENERATED BY THE SYNCHRON LXI 725 CLINICAL SYSTEM FOR TWO PATIENTS. PATIENT A: THE INITIAL RESULT WAS 14.91NG/ML AND 0.08NG/ML UPON REPEAT. THE SAMPLE WAS ALSO TESTED ON A DIFFERENT INSTRUMENT AND A RESULT OF 0.10NG/ML WAS OBTAINED. PATIENT B: THE INITIAL RESULT WAS AN "IND" FLAG (IND FLAG INDICATED THAT THE SAMPLE RELATIVE LIGHT UNITS (RLU) READING IS BELOW THE S0 CALIBRATOR'S RLU MEAN VALUE). THE SAMPLE WAS RE-TESTED AND REPEATED RESULTS WERE: 7.65NG/ML AND 0.00NG/ML. A RESULT OF 0.01NG/ML WAS GENERATED FOR THIS SAMPLE BY THE DIFFERENT INSTRUMENT. THE RESULTS OBTAINED FROM THE DIFFERENT INSTRUMENT WERE REPORTED FOR BOTH PATIENTS. PER CUSTOMER, THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. PATIENT TREATMENT WAS NOT AFFECTED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® I 725 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1