BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3100554 · Received May 8, 2013

    Report

    Report Number
    2050012-2013-00326
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL (QC) PRIOR TO THE EVENT WAS LOW AND EXHIBITED THE ISSUE. HOWEVER, THE LAB-ESTABLISHED RANGE IS WIDE, AND THE QC FELL WITHIN RANGE. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND NOTED THAT THE FLOWCELL WAS DIRTY AND FOUND A BUBBLE ON THE FACE OF THE NA ELECTRODE. THE FSE REPLACED THE ELECTRODE AND CLEANED THE FLOWCELL. MDR 2050012-2013-00327 IS RELATED TO THIS EVENT AND DOCUMENTS THE FALSE LOW NA RESULT OBTAINED ON (B)(6)2013.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER GENERATED FOUR (4) FALSE LOW SODIUM (NA) PATIENT RESULTS ON TWO (2) DIFFERENT DAYS ((B)(6) 2013). THIS REPORT DOCUMENTS THE THREE (3) FALSE NA PATIENT RESULTS GENERATED ON (B)(6) 2013. THE FALSE LOW RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. WHEN THE ISSUE WAS NOTICED, THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT IN THE LABORATORY AND THOSE RESULTS WERE REPORTED. THE CUSTOMER INDICATED THAT ONLY NA RESULTS WERE AFFECTED IN THIS EVENT. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THIS REPORT. PATIENT TREATMENT WAS NOT IMPACTED FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200467 UNICEL® DXC 600 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR