BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO ANALYZER

    MDR report key: 3053110 · Received April 11, 2013

    Report

    Report Number
    2050012-2013-00227
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ISSUES NOTED WERE NOTED WITH CALIBRATION OR QC (QUALITY CONTROL) RECOVERY BEFORE THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE AND FOUND THE MC (MODULAR CHEMISTRY) VACUUM/WASTE LINES 175 AND 158 CLOGGED WITH GLUCOSE REAGENT RESIDUE. THE FSE FLUSHED OUT THESE LINES ASSOCIATED WITH THE GLUCOSE MODULE WHICH RESOLVED THE ISSUE. THE FSE INCIDENTALLY REPLACED THE REAGENT STRAW. THE CAUSE OF THIS EVENT MAY BE ATTRIBUTED TO THE CLOGGED MC VACUUM/WASTE LINES ASSOCIATED WITH THE GLUCOSE MODULE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT FIVE MODULAR GLUCOSE (GLUM) FALSE HIGH PATIENT RESULTS GENERATED BY A SYNCHRON LX20 PRO ANALYZER. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER WAS RUNNING GLUCOSE IN CRITICAL RERUN MODE. RERUNS WERE PERFORMED AND RESULTS WERE REPORTED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155957 SYNCHRON® LX20 PRO ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER LX 20 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1