BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2873206 · Received December 13, 2012

    Report

    Report Number
    2050012-2012-01910
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CFR
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND INSPECTED THE SYSTEM. THE FSE FOUND THE MANIFOLD FLUIDIC LINES WERE INCORRECTLY CONNECTED CAUSING DILUTE WASH SOLUTION TO FLOW TO THE MODULAR CHEMISTRY SAMPLE PROBE INTERNALLY, WHICH IN TURN APPLIED A VOLTAGE TO THE PROBE CAUSING MODULAR CHEMISTRY SIDE CHEMISTRY PROBLEMS. THE FSE CORRECTED THE FLUIDIC CONNECTIONS. IT IS UNKNOWN HOW OR WHEN THESE FLUID LINES WERE INCORRECTLY CONNECTED. THIS MANIFOLD IS NOT ACCESSIBLE BY THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AND REPORTED THAT 3-4 ERRONEOUSLY LOW PLASMA GLUCOSE MODULAR (GLUM) RESULTS WERE GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER PROVIDED RESULTS FOR ONLY ONE OF THE FOUR PATIENT RESULTS. RERUNS OF THESE SAMPLES ON ANOTHER INSTRUMENT YIELDED HIGHER GLUCOSE RESULTS. THE ION-SELECTIVE ELECTRODE (ISE) RESULTS FOR THESE PATIENTS WERE QUESTIONED AS WELL; HOWEVER, THE ISE RESULTS BEFORE AND AFTER WERE WITHIN ESTABLISHED PRECISION CLAIMS. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR CHANGES TO THE PATIENTS' CARE OR TREATMENT. A BECKMAN COULTER FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE TO EVALUATE THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE CFR BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1