BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO ANALYZER

    MDR report key: 2469929 · Received February 27, 2012

    Report

    Report Number
    2050012-2012-00581
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 6, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC HOTLINE HAD THE CUSTOMER TIGHTEN THE SAMPLE DETECTOR AND CLEAN THE CUP, PRIME THE MODULE TO CHECK FOR FILLING/DRAINING AND BUBBLES. THE CUSTOMER WAS ALSO INSTRUCTED TO PERFORM A LAMP CALIBRATION. NO FURTHER ISSUES WERE NOTED. A CLEAR ROOT CAUSE FOR THIS EVENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING ONE HIGH PHOSPHOROUS (PHOS) PATIENT RESULT OF 9.6MG/DL GENERATED BY THEIR SYNCHRON LX20 PRO ANALYZER. BEC FIELD SERVICE ENGINEER (FSE) WAS ON-SITE A WEEK BEFORE THE EVENT DUE TO A NOISE ERROR. PER FSE, THE PROBLEM WAS A LOOSE MODULE. FSE TIGHTENED THE MODULE. THE MORNING OF THE EVENT, CUSTOMER WAS HAVING PROBLEMS WITH NOISE AND FAILING RANGE WHEN TRYING TO CALIBRATE. THE CUSTOMER WAS USING PHOS REAGENT LOT# M103025 THAT WAS LOADED ON (B)(6) 2012. THE CALIBRATION PASSED ON THE THIRD CALIBRATION, AND THE QC PASSED. THE CUSTOMER THEN RAN SAMPLES AND GOT THE CRITICAL HIGH 9.6MG/DL PHOS RESULT. THE CUSTOMER STOPPED RUNNING PHOS ON THIS INSTRUMENT. THE SAMPLE WAS REPEATED ON A DIFFERENT INSTRUMENT AND GAVE A RESULT OF 3.2MG/DL. THE REAGENT IN USE ON THIS INSTRUMENT WAS LOT# M108199. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO AFFECT TO PATIENT WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1