BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CLINICAL SYSTEM

    MDR report key: 1973230 · Received January 28, 2011

    Report

    Report Number
    2050012-2011-00199
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 31, 2010
    Report Date
    December 31, 2010
    Product Code
    JJE
    PMA / PMN Number
    K965240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. QC PERFORMED AFTER THE EVENT WAS LOW. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE CLEANED THE FLOW-CELL AND FLUSHED THE REAGENT TUBING WITH DECONTAMINATION SOLUTION. THE FSE CALIBRATED AND CHECKED QC. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER STATED THAT SODIUM (NA) AND CHLORIDE (CL) RESULTS DRIFTED LOW ON SYNCHRON LX20 PRO CLINICAL SYSTEM. WHEN THE LOW RESULTS WERE NOTICED, SAMPLES WERE REPEATED ON A DIFFERENT INSTRUMENT IN THE LAB WHICH GENERATED HIGHER RESULTS. QA REVIEW OF THE DATA SHOWS THAT THE DIFFERENCE IN CL RECOVERY WAS WITHIN THE PRECISION OF THE ASSAY. THE CUSTOMER FORWARDED 29 SAMPLES THAT HAD DISCREPANT NA RESULTS. OF THE 29, THE DIFFERENCES IN 20 SAMPLES WERE WITHIN THE PRECISION OF THE ASSAY. OF THE TOTAL, 9 HAD BEEN REPORTED OUT OF THE LAB AND REQUIRED AMENDED RESULTS. TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE FALSE LOW RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE LX20 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1