BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 3007898 · Received March 16, 2013

    Report

    Report Number
    2050012-2013-00164
    Event Type
    Malfunction
    Date Received
    March 16, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: FRAGMENT DEBRIS IN THE ELECTROLYTE INJECTION CUP (EIC), EIC LOWER BLOCK AND EIC QUAD RING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY LOW CHLORIDE (CL) RESULTS AND/OR HIGH CALCIUM (CALC) RESULTS FOR TWO PATIENT SAMPLES INVOLVING A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER REPEATED THE SAMPLES ON AN ALTERNATE ANALYZER WHEN THE ISSUE WAS NOTICED AND THE RESULTS WERE REPORTED OUT OF THE LABORATORY. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. QUALITY CONTROL PRIOR TO AND AFTER THE EVENT WERE WITHIN THE LABORATORY'S ESTABLISHED RANGES. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND NOTED METAL FRAGMENT DEBRIS IN THE ELECTROLYTES INJECTION CUP (EIC) CAUSING COMPROMISED DRAINING. THE FSE REPLACED THE EIC LOWER BLOCK AND QUAD RING AND THE CALCIUM ELECTRODE. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111064 UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1