BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX® I 725 CLINICAL SYSTEM

    MDR report key: 3243743 · Received July 23, 2013

    Report

    Report Number
    2050012-2013-00511
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE THIS INCIDENT AND THE RESULTS ARE WITHIN THE ESTABLISHED RANGES. THE FSE FOUND THE CREM CUP WAS NOT DRAINING PROPERLY. THE FSE PERFORMED MAINTENANCE, PRIMED CLEANING FLUID THROUGH THE REAGENT LINES WHICH RESOLVED THE ISSUE. QUALITY CONTROL (QC) WAS RUN AND THE RESULTS ARE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING AN ONSITE SERVICE VISIT FROM A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE), THE FSE REPORTED THAT THE CUSTOMER'S SYNCHRON LX I 725 CLINICAL SYSTEM GENERATED TWO (2) FALSE LOW CREATININE MODULAR CHEMISTRY (CREM) PATIENT RESULTS. THE FALSE LOW CREM RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER ALSO NOTICED THAT THE INSTRUMENT WAS GENERATING "MODULAR CHEMISTRY (MC) REAGENT LEVEL HIGH IN REACTION CUP" ERRORS. THE CUSTOMER RAN CONTROLS AND YIELDED OUT OF THE LOW RANGE RESULTS. THE CUSTOMER ATTEMPTED TO RE-CALIBRATE THE SYSTEM, BUT FAILED. THE SAMPLES WERE RE-RAN AFTER SERVICE WAS PERFORMED AND YIELDED WITHIN NORMAL. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN SECTION B6 OF THIS REPORT. THERE WAS NO IMPACT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342275 SYNCHRON® LX® I 725 CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER LX® I 725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR