BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX®I 725 CLINICAL SYSTEM

    MDR report key: 1580104 · Received January 19, 2010

    Report

    Report Number
    2050012-2010-00007
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    December 14, 2009
    Report Date
    January 19, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CHH
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN CUSTOMER SPECIFICATIONS BEFORE THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE AND REPAIRED, REPLACED OR ALIGNED THE SAMPLE AND REAGENT SYRINGE SYSTEM COMPONENTS, THE SAMPLE AND REAGENT PROBE SYSTEM COMPONENTS, AND THE SAMPLE AND REAGENT MIXER SYSTEM COMPONENTS. DUE TO A POTENTIAL FOR THIS EVENT TO RECUR UNKNOWINGLY, THERE IS POTENTIAL THAT A PIVOTAL ASSAY COULD BE ERRONEOUSLY REPORTED AND TREATMENT DECISION MAY BE AFFECTED. 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 MULTIPLE FALSELY HIGH CHOLESTEROL, TRIGLYCERIDE AND HDL-CHOLESTEROL RESULTS GENERATED BY THE SYNCHRON LXI 725 CLINICAL SYSTEM. THE INITIAL CHOLESTEROL, TRIGLYCERIDE AND HDL RESULTS WERE IN THE RANGE 230-452, 108-1046 AND 39-111 UNITS RESPECTIVELY; AND THE REPEAT RESULTS WERE IN THE RANGE 150-299, 66-615 AND 30-72 UNITS RESPECTIVELY. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE LABORATORY BELIEVES THAT ONE OR TWO PATIENTS WERE PRESCRIBED MEDICATION BASED ON THE ERRONEOUS RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1