BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 2552398 · Received April 29, 2012

    Report

    Report Number
    2050012-2012-01025
    Event Type
    Malfunction
    Date Received
    April 29, 2012
    Date of Event
    April 3, 2012
    Report Date
    April 4, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE SYNCHRON LXI 735 CLINICAL SYSTEM (LXI 725) CREM (CREATININE MODULE CHEMISTRY) QC (QUALITY CONTROL) GAVE INTERMITTENT REACTION NOISE ERRORS. CUSTOMER REPORTED THAT THEY HAD TO RECALIBRATE THE LXI 725 SEVERAL TIMES BECAUSE THE INSTRUMENT GAVE BACK TO BACK ERRORS. CUSTOMER REPORTED THAT ERRONEOUS CREATININE PATIENT RESULTS WERE GENERATED. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT A DOCTOR QUESTIONED THE RESULTS OF TWO PATIENT SAMPLES. CUSTOMER REPORTED THAT THEY RERAN THE TWO SAMPLES ON ANOTHER INSTRUMENT AND AMENDED THE RESULTS. CUSTOMER REPORTED THAT PATIENT TREATMENT WAS NOT CHANGED. CUSTOMER INDICATED THAT THEY RERAN PATIENT SAMPLES AFTER THE DOCTOR QUESTIONED THE RESULTS OF THE TWO PATIENT SAMPLES. CUSTOMER REPORTED THAT THERE WERE A TOTAL OF 56 ERRONEOUS RESULTS GENERATED. CUSTOMER REPORTED THAT THEY AMENDED THE ERRONEOUS RESULTS. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE STIRRER MOTOR WAS MAKING A GRINDING NOISE. THE FSE REPLACED THE MOTOR AND RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX I 725 CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR