BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® 20 PRO CLINICAL SYSTEM

    MDR report key: 1942642 · Received December 30, 2010

    Report

    Report Number
    2050012-2010-01764
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN THE ESTABLISHED RANGES. QC AFTER RECALIBRATION WAS ALSO WITHIN THE ESTABLISHED RANGES. THE CUSTOMER STATED THAT RECALIBRATION BRINGS THE SODIUM RECOVERIES BACK UP TO THE RANGES, BUT THEN THE RECOVERIES DRIFT LOW AGAIN. THE CUSTOMER EXPERIENCED SIMILAR ISSUES WITH ANOTHER INSTRUMENT IN THE LAB (MEDWATCH REPORT #2050012-2010-01772). THE CUSTOMER REPORTED THAT BETWEEN THE TWO INSTRUMENTS, APPROXIMATELY 60 FALSE LOW SODIUM RESULTS HAD BEEN REPORTED AND HAD TO BE AMENDED. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED PREVENTIVE MAINTENANCE ON THE INSTRUMENT. ON (B)(6) 2010, THE CUSTOMER CALLED BACK FOR ONGOING SODIUM DRIFT ISSUE. ON (B)(6) 2010, THE FSE REPLACED THE SAMPLE PROBE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW SODIUM (NA) RESULTS INTERMITTENTLY GENERATED BY SYNCHRON LX 20 PRO CLINICAL SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AND THE REPORTS WERE AMENDED WITH THE HIGHER RESULTS. AS OF (B)(6) 2010, THE CUSTOMER HAD NOT RECEIVED ANY REPORTS FROM PHYSICIANS OF IMPACT TO PATIENT CARE BASED UPON THE ERRONEOUSLY LOW RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® 20 PRO CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JGS BECKMAN COULTER, INC. LX20 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1