BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 PRO SYNCHRON SYSTEM

    MDR report key: 5651013 · Received May 12, 2016

    Report

    Report Number
    2050012-2016-00168
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Date of Event
    April 27, 2016
    Report Date
    April 27, 2016
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K103842
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING SERVICE VISIT A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED INSTRUMENT AND FOUND BUBBLES IN TUBE LINE 12, 24 AND LINE 27. FSE REPLACED TUBE LINE 12, 24, 27 AND RATIO PUMP WHICH RESOLVED THE ISSUE. FSE PRIMED THE INSTRUMENT AND RAN QUALITY CONTROLS WITHOUT ERRORS. INSTRUMENT RESUMED OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY GENERATED FALSE HIGH AND LOW RESULTS FOR SODIUM (NA), CHLORIDE (CL) AND CALCIUM (CALC) WITH HIGH ANION GAP ON THEIR UNICEL DXC 600 PRO SYNCHRON SYSTEM. THE FALSE HIGH AND LOW PATIENT RESULTS WERE NOT REPORTED OUT OF LABORATORY. THERE WAS NO EFFECT TO PATIENT TREATMENT IN CONNECTION TO EVENT. QUALITY CONTROL PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. IN ADDITION, ANION GAP IS A TOOL TO ASSESS THE INTEGRITY OF THE INDIVIDUAL ANALYTE AND THIS IS NOT A DIAGNOSTIC TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306784 UNICEL DXC 600 PRO SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1