BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 1120664 · Received August 14, 2008

    Report

    Report Number
    2122870-2008-00249
    Event Type
    Other
    Date Received
    August 14, 2008
    Date of Event
    July 22, 2008
    Report Date
    August 14, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN 4.5 ML PLASTIC LITHIUM HEPARIN TUBES AND CENTRIFUGED AT 3000 RPM FOR 10 MINS. LABORATORY HAS A POLICY TO REPEAT ALL ACCUTNI PATIENT SAMPLES THAT RESULT >0.04/ML. QC WAS WITHIN SPECIFICATIONS IN 2008. CUSTOMER OBTAINED FAILING SYSTEM CHECK EARLY OF THE MONTH, WHICH PASS UPON REPEAT SYSTEM CHECK THE SAME DAY, WHICH PASSED UPON REPEAT. SYSTEM CHECK PERFORMED THE DAY PRIOR TO ORIGINAL DATE, MET SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS ONSITE FIVE DAYS PRIOR: FSE PERFORMED SYSTEM PROTOCOL AND RAN SYSTEM CHECK WHICH PASSED. FSE PERFORMED DIAGNOSTIC TESTING WHICH MET SPECIFICATIONS. FSE REPLACED SAMPLE PIPETTOR TIP AND ADJUSTED THE ULTRASONIC'S. NO HARDWARE ISSUES WERE NOTED FOR THIS EVENT. FSE REPLACED ASPIRATION TUBING AS PRECAUTION. FSE FOLLOW-UP WITH THE CUSTOMER EIGHT DAYS AFTER THE ORIGINAL DATE, IN REGARDS TO THIS EVENT AND THE CUSTOMER NOTED NO FURTHER ISSUES. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. 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 AN ERRONEOUSLY LOW ACCUTNI RESULT, GENERATED BY THE SYNCHRON LX I 725 CLINICAL SYSTEM FOR ONE PATIENT. CUSTOMER TESTED A SAMPLE FOR ACCUTNI AND OBTAINED A RESULT OF 0.28NG/ML. THE SAMPLE WAS THEN ALIQUOTED, RE-SPUN AND RE-ANALYZED ON 2 DIFFERENT INSTRUMENT UPON WHICH IT GAVE RESULTS OF 0.67NG/ML AND 0.61NG/ML. THE SAME SAMPLE WAS THEN RE-ANALYZED ON THE ORIGINAL INSTRUMENT AND IT GAVE A RESULT OF 0.61NG/ML. UPON REPEAT THROUGH THE CLOSED TUBE ACCESSING SYSTEM (CTA), IT AGAIN GAVE A RESULT OF 0.61NG/ML. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THERE WAS NOT EFFECT TO PATIENT OR USER IN ASSOCIATION TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA