BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 1298372 · Received January 26, 2009

    Report

    Report Number
    2050012-2009-00004
    Event Type
    Other
    Date Received
    January 26, 2009
    Date of Event
    January 7, 2009
    Report Date
    January 26, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS DRAWN IN A PLASTIC , GEL SEPARATOR LITHIUM HEPARIN TUBE. QC IS RUN THROUGH THE CTA (CLOSED TUBE ACCESSING) BUT WAS NOT AFFECTED. HOWEVER, NO QC REPORTS WERE PROVIDED. FIELD SERVICE ENGINEER (FSE) HAD VISITED A FEW DAYS PREVIOUSLY FOR THIS ISSUE AND HAD VERIFIED THAT THE SYSTEM WAS FUNCTIONING APPROPRIATELY. FSE VISITED AFTER THIS INCIDENT AND REPLACED THE CTA ALIQUOT PROBE, PERFORMED ALIGNMENTS, AND REPLACED THE TUBING AND SYRINGES. THE SYSTEM IS PERFORMING ACCEPTABLY NOW. BCI REPRESENTATIVE HAS REQUESTED RETURN OF THE PARTS REPLACED FOR FURTHER INVESTIGATION. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE, AND 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 ERRONEOUS RESULTS, GENERATED BY THE SYNCHRON LX I 725 CLINICAL SYSTEM FOR ONE PATIENT. THE PATIENT SAMPLE GAVE A MYOGLOBIN (MYO) RESULT OF 52.7NG/ML, CKMB RESULT OF 5.2NG/ML AND WHEN TESTED FOR ACCUTNI, IT GAVE A QNS FLAG (INSUFFICIENT VOLUME OF SAMPLE) AND NO VALUE WAS OBTAINED. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS SAMPLE WAS THEN RETESTED ON A DIFFERENT INSTRUMENT, UPON WHICH IT GAVE A MYO RESULT OF 121.9NG/ML, CKMB RESULTS OF 8.8 AND 9.3NG/ML AND AN ACCUTNI RESULT OF 0.11NG/ML. CORRECTED RESULTS WERE REPORTED OUT. THERE WAS NO EFFECT TO PATIENT OR USER WITH REGARDS TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX I 725 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA