BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 CLINICAL SYSTEM

    MDR report key: 2060206 · Received April 15, 2011

    Report

    Report Number
    2050012-2011-01102
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGA
    PMA / PMN Number
    K965240
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE SERUM TYPE. CUSTOMER NOTICED THEIR QC HAD DRIFTED LOW AFTER THESE SAMPLES WERE RUN AND REPORTED. CUSTOMER DECLINED SERVICE CALL UNTIL THEY PERFORMED 4 MONTH MAINTENANCE THAT WAS DUE, TAPED A BUBBLE OUT FROM THE FACE OF THE GLUCOSE ELECTRODE, FOUND A LOOSE REAGENT TUBING FITTING AND CORRECTED, RECALIBRATED AND QC WAS NOW IN SPECIFICATIONS. CUSTOMER WAS UP AND RUNNING TO THEIR SATISFACTION WHEN HOTLINE CALLED BACK THE NEXT DAY. ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT THREE (3) ERRONEOUSLY LOW GLUCOSE (GLUCM) PATIENT RESULTS WERE GENERATED BY THE SYNCHRON LX20 CLINICAL SYSTEM AFTER QC LOW DRIFT OCCURRED. THE RESULTS WERE REPORTED OUT OF THE LAB. CUSTOMER RE-TESTED PATIENT SAMPLES ON A DIFFERENT INSTRUMENT AND AMENDED THE RESULTS. CUSTOMER DID NOT THINK PATIENT TREATMENT WAS AFFECTED BASED ON THE SMALL DIFFERENCE BETWEEN ERRONEOUS AND AMENDED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER CGA BECKMAN COULTER INC. LX20, WO CAP PIERCER

    Patients

    Seq Age Sex Outcome Treatment
    1