BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX®I 725 CLINICAL SYSTEM

    MDR report key: 1570133 · Received January 5, 2010

    Report

    Report Number
    2050012-2010-00002
    Event Type
    Malfunction
    Date Received
    January 5, 2010
    Date of Event
    December 10, 2009
    Report Date
    January 5, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJC
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE DRAWN IN SST PLASMA TUBES. QC WAS WITHIN SPECIFICATIONS BEFORE THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE AND REPLACED THE SAMPLE SYRINGE AND T-VALVE WHICH RESOLVED THE PROBLEM. QC AND PATIENT SAMPLES WERE RUN TO VERIFY SYSTEM PERFORMANCE. THE REPLACED PARTS HAVE BEEN REQUESTED FOR INVESTIGATION. 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 LOW MAGNESIUM (MG) RESULTS GENERATED BY THE SYNCHRON LXI 725 CLINICAL SYSTEM. THE INITIAL MG RESULTS WERE IN THE RANGE 0.1-1.4 MG/DL AND THE REPEAT RESULTS WERE IN THE RANGE 1.8-2.1 MG/DL. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND CORRECTED REPORTS WERE ISSUED. IT IS UNKNOWN IF THERE WAS AN AFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1