BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX®I 725 SYSTEM

    MDR report key: 3537086 · Received December 25, 2013

    Report

    Report Number
    2050012-2013-00825
    Event Type
    Malfunction
    Date Received
    December 25, 2013
    Date of Event
    December 5, 2013
    Report Date
    December 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DETERMINED THE EIC VALVE P/N 473136 WAS NOT FUNCTIONING CAUSING THE EIC TO LEAK. THE FSE REPLACED THE EIC VALVE WHICH RESOLVED THE ISSUE, NO FURTHER LEAKS WERE OBSERVED. THIS FAILURE MODE CAN IMPACT ANY OR ALL CHEMISTRIES, INCLUDING CRITICAL CHEMISTRIES. THE MANUFACTURER REFERENCE NUMBER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CONTAINED LEAK FROM THE ELECTROLYTE INJECTION CUP (EIC) ON A SYNCHRON LXI 725 INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT; NO REPORTS OF EXPOSURE OR INJURY WERE REPORTED. NO ERRONEOUS RESULTS WERE GENERATED OR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675057 SYNCHRON® LX®I 725 SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER SLGP, LXI 725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1