BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CLINICAL SYSTEM

    MDR report key: 2083679 · Received May 10, 2011

    Report

    Report Number
    2050012-2011-01602
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE INITIAL COMPLAINT WAS AGAINST BOTH SODIUM (NA) AND CHLORIDE (CL), THE ONLY RESULTS CORRECTED WERE SODIUM RESULTS. THE CUSTOMER STATED THAT QC WAS WITHIN THE ESTABLISHED RANGES. SERVICE WAS DISPATCHED FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE CARBON BRIDGE, CLEANED THE FLOWCELL, AND REPLACED THE CHLORIDE ELECTRODE TIP. THE FSE VERIFIED THE INSTRUMENT PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO THIRTY THREE (33) ERRONEOUSLY LOW SODIUM (NA) RESULTS GENERATED BY SYNCHRON LX20 PRO CLINICAL SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. REPEAT TESTING PRODUCED HIGHER RESULTS, AND CORRECTED REPORTS WERE ISSUED. THE RESULTS ARE SHOWN IN THE ATTACHED FILE. PATIENT TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE ERRONEOUS RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1