BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LX20 PRO

    MDR report key: 925238 · Received October 9, 2007

    Report

    Report Number
    2050012-2007-00032
    Event Type
    Other
    Date Received
    October 9, 2007
    Date of Event
    September 21, 2007
    Report Date
    October 9, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC IS RUN ONCE PER SHIFT, AND WAS NOT AFFECTED. QC WAS NOT PERFORMED AFTER THE EVENT. BASED ON AVAILABLE INFORMATION, THE CUSTOMER HAD OBSTRUCTION DETECTION TURNED DISABLED, ALTHOUGH THIS FEATURE IS USUALLY ENABLED. THE CUSTOMER CALLED BECKMAN COULTER INC. (BCI) ABOUT MODULAR CHEMISTRY (MC) RESULTS SUPPRESSED, CAUSING CUP MODULES TO BE DISABLED, A) THE CUSTOMER WAS ADVISED TO FLUSH, OR CHANGE THE SAMPLE PROBE. THE CUSTOMER CALLED BACK LATER THE SAME DAY STATING THEY WERE GETTING MC SYRINGE ERROR AFTER TWO POWER DOWNS. A) A SERVICE WAS ORDERED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB IN 2007: A) THE FSE NOTED THAT THE CUSTOMER HAD BEEN GETTING SAMPLE/SYRINGE ERRORS. B) THE FSE OBSERVED THAT THE AFFECTED SAMPLES APPEARED TO HAVE MORE VOLUME THAN USUAL. C) THE FSE PRIMED THE INSTRUMENT AND DISCOVERED THAT LIQUID WAS COMING FROM WHERE THE OBSTRUCTION DETECTION TRANSDUCER MEMBRANE WOULD BE. D) THE FSE REPLACED A SAMPLE CRANE ASSEMBLY WHICH FIXED THE PROBLEM. ALTHOUGH HARDWARE WAS REPLACED BY THE FSE, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED IN THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW POTASSIUM (K) RESULTS THERE WERE GENERATED BY THE SYNCHRON LX20 PRO INSTRUMENT. THE CUSTOMER INDICATED THAT THE LAB REPORTED OUT LOW K RESULTS FOR MULTIPLE PATIENTS. ACTUAL K RESULTS WERE NOT PROVIDED; HOWEVER, THE RESULTS WERE ABOUT 25% LOW. THE CUSTOMER REPEATED TESTING FOR K ON A DIFFERENT INSTRUMENT IN THEIR LAB AND THESE RESULTS ALSO WERE LOW. IT IS UNKNOWN HOW MANY SAMPLES WERE AFFECTED, BUT 52 PATIENT RESULTS WERE CANCELED, AND THE PATIENTS RECALLED FOR REDRAWS. IT IS UNKNOWN IF PATIENT TREATMENT WAS AFFECTED AS RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR