BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CLINICAL SYSTEM

    MDR report key: 2221084 · Received August 23, 2011

    Report

    Report Number
    2050012-2011-04720
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERUM OR PLASMA. NO OTHER INFORMATION WAS PROVIDED. QC PRIOR TO AND AFTER THE EVENT WAS WITHIN THE ESTABLISHED RANGES. THE CUSTOMER PROVIDED DATA FROM 14 SAMPLES. THE DIFFERENCES IN SODIUM (NA) RESULTS FOR OF THE SAMPLES WERE WITHIN THE ASSAY PRECISION CLAIMS AND ARE NOT INCLUDED. MANY CHLORIDE (CL) RESULTS WERE WITHIN THE PRECISION CLAIM OF THE ASSAY AND ARE NOT INCLUDED. SERVICE REPLACED THE CARBON BRIDGE AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT ERRONEOUSLY HIGH SODIUM (NA) AND CHLORIDE (CL) RESULTS WERE GENERATED BY SYNCHRON LX20 PRO CLINICAL SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE RERUN AFTER TROUBLESHOOTING RESOLVED THE PROBLEM AND THOSE RESULTS WERE REPORTED. THE PATIENT RESULTS ARE SHOWN. THERE WAS NO IMPACT TO THE PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. LX20 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1