BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I725 CLINICAL SYSTEM

    MDR report key: 1203153 · Received October 17, 2008

    Report

    Report Number
    2122870-2008-00330
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS DURING THE TIME OF THE EVENT. A SYSTEM CHECK PERFORMED IN 2008 MET SPECIFICATIONS. THE SPECIMENS WERE COLLECTED IN 13 X 100 GREINER SST TUBES AND CENTRIFUGED AT 3,000 RPM FOR 10 MINUTES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE PERFORMED HARDWARE VERIFICATION TESTS. THE FSE CONDUCTED PRECISION AND DIAGNOSTIC TESTING AND BOTH MET SPECIFICATIONS. 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 A FALSE NEGATIVE (-) TOTAL BHCG (TBHCG) RESULT GENERATED BY THE SYNCHRON LX I725 INSTRUMENT FOR ONE PATIENT. A PATIENT SAMPLE WAS TESTED FOR TBHCG AND A RESULT OF 0.24MIU/ML WAS REPORTED OUT OF THE LAB. THE SAMPLE WAS RETESTED AND REPEATED RESULT WAS 12,373MIU/ML. A SAMPLE FROM THIS PT WAS TESTED FOR TBHCG TWO DAYS AGO ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND A RESULT OF 7,513MIU/ML WAS OBTAINED AND REPORTED OUT OF THE LAB. THE SAMPLE GAVE A RESULT OF "APPROX 7,500MIU/ML" UPON REPEAT. A THIRD SAMPLE WAS TESTED ON THE LXI INSTRUMENT AND A RESULT OF 12,496MIU/ML WAS OBTAINED. THE DIFFERENT INSTRUMENT GENERATED RESULT OF "APPROX 12,000MIU/ML". THERE WAS NO EFFECT TO PT IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX I725 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA