BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX®20 PRO SYSTEM

    MDR report key: 3081757 · Received April 29, 2013

    Report

    Report Number
    2050012-2013-00286
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND NOTICED THAT THE SAMPLE MIXER WASH STATION WAS NOT RECEIVING FLUID. THE FSE REBUILT THE MANIFOLD VALVE TO RESOLVE THE ISSUE AND PERFORMED MAGNESIUM PRECISION RUN TO VERIFY INSTRUMENT'S OPERATION. RESULTS MET PUBLISHED PRECISION SPECIFICATIONS AND FAILURE MODE IS ATTRIBUTED TO THE MANIFOLD VALVE ON THE SAMPLE MIXER WASH STATION. THIS REPORT REFERENCES THE EVENT WHICH OCCURRED ON (B)(6) 2013. PLEASE REFER TO MEDWATCH #2050012-2013-00285 FOR A RELATED REPORT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY HIGH MAGNESIUM RESULTS FOR FIFTEEN (15) PATIENTS, OVER TWO (2) DAYS, INVOLVING THE SYNCHRON LX20 PRO SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY BUT THE CUSTOMER IS UNAWARE OF ANY CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPEATED THE SAMPLES AND ISSUED AMENDED RESULTS FOR MAGNESIUM. THE CUSTOMER INDICATED THAT ALL OTHER CHEMISTRIES PERFORMED WITHIN SPECIFICATIONS. CALIBRATION AND QC (QUALITY CONTROLS) PASSED WITHIN SPECIFICATIONS PRIOR TO THE EVENT. MAGNESIUM REAGENT LOT NUMBER M211286 WAS USED IN CONJUNCTION WITH THE ANALYZER FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185769 SYNCHRON LX®20 PRO SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1