BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 742302 · Received July 13, 2005

    Report

    Report Number
    2122870-2005-00098
    Event Type
    Other
    Date Received
    July 13, 2005
    Date of Event
    June 18, 2005
    Report Date
    July 13, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT QC WAS WITHIN SPECIFICATIONS PRIOR TO THE EVENT. SYSTEM CHECK PERFORMED ON 06/15/05 PASSED. PT SAMPLES WERE COLLECTED IN BECTON DICKINSON PLASTIC LITHIUM HEPARIN TUBES WITHOUT GEL SEPARATORS AND CENTRIFUGED AT 8,500 RPM FOR 3 MINS IN A STAT SPIN CENTRIFUGE. SERVICE SUMMARY (POST EVENT): A) A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER LAB. THE FSE PERFORMED A DIAGNOSTIC TEST WHICH PASSED. THE FSE INDICATED THAT QC WAS WITHIN CUSTOMER'S SPECIFICATIONS. THE FSE VERIFIED THAT THE INSTRUMENT WAS OPERATING PER ESTABLISHED PROCEDURES. 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 REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT FROM A SINGLE PT THAT WAS GENERATED BY THE SYNCHRON LX I 725 INSTRUMENT. THE ELEVATED ACCU TNI RESULT WAS 4.00NG/ML. THE RESULT WAS REPORTED OUT OF THE LAB. A FRESH SAMPLE WAS COLLECTED FROM THE PT EIGHT (8) HRS LATER AND TESTED FOR ACCU TNI. THE RESULT WAS 0.40NG/ML. THE CUSTOMER THEN RE-PEATED THE PT 1ST SAMPLE FOR ACCU TN. THE REPEAT ACCU TNI RESULT WAS 0.40NG/ML. NO ADDITIONAL EVENT INFO WAS PROVIDED. THE CUSTOMER INDICATED THAT THERE HAS BEEN NO CHANGE TO PT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other