BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 1104945 · Received August 7, 2008

    Report

    Report Number
    2122870-2008-00240
    Event Type
    Other
    Date Received
    August 7, 2008
    Date of Event
    July 11, 2008
    Report Date
    August 7, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN A PLASTIC BD TUBE WITH GEL. ACCUTNI QC RESULTED WITHIN SPECIFICATIONS DURING THE TIME OF THE EVENT. SYSTEM CHECKS PERFORMED TWO TIMES IN THE SAME MONTH IN 2009 RECOVERED WITHIN SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE TWO DAYS LATER: FSE RAN A SYSTEM CHECK AND ADJUSTED THE DRIFT CORRECTION. FSE RERAN SYSTEM CHECK AND RESULTS MET SPECIFICATIONS. FSE RAN DIAGNOSTIC TESTING WHICH PASSED. FSE RAN PRECISION TESTING USING ACCUTNI QC LEVEL ONE WHICH PASSED. FSE SPOKE WITH THE CUSTOMER ABOUT INVERTING PACKS PRIOR TO LOADING. FSE NOTED ROUTINE ACCUTNI QC PERFORMED RESULTED WITHIN RANGE AND THE CUSTOMER RESUMED PT TESTING. FSE VERIFIED THE INSTRUMENT PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. FSE SPOKE WITH THE CUSTOMER THE NEXT DAY, AND NOTED THE SYSTEM TO BE OPERATING WITHOUT ERROR. 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 ELEVATED ACCUTNI RESULT, GENERATED BY THE SYNCHRON LX I 725 CLINICAL SYSTEM FOR ONE PT. CUSTOMER TESTED A SAMPLE FOR ACCUTNI AND OBTAINED A RESULT OF 2.39NG/ML. UPON REPEAT, IT GAVE A RESULT OF 0.17NG/ML AND WHEN REPEATED ON A DIFFERENT INSTRUMENT A RESULT OF 0.19NG/ML WAS OBTAINED. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT REPORT PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT ATTRIBUTED OR CONNECTED WITH 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