BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3093027 · Received May 3, 2013

    Report

    Report Number
    2050012-2013-00311
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE MODE TO ERRONEOUS RESULTS WAS DUE TO A LOOSE REAGENT SYRINGE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER WAS GENERATING "CHEMISTRY CARTRIDGE (CC) CUVETTE NOT DRY" ERROR MESSAGES FOR REAGENT PROBE A AND B. IT WAS CONFIRMED THAT THE CC CUVETTE WAS NOT DRY. CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING AND DISCOVERED THAT THE SYRINGE WAS LOOSE. THE CUSTOMER ALSO OBSERVED THAT THERE WAS A SMALL AMOUNT OF LIQUID IN THE REAGENT CAROUSEL DRIP TRAY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES DURING THIS EVENT. THE MATERIAL SAFETY DATA SHEETS (MSDS) WAS NOT REVIEWED AND THE FACILITY DOES HAVE A RISK MANAGEMENT PLAN. CUSTOMER TIGHTENED THE SYRINGE, REPEATED QUALITY CONTROL (QC) FOR THE CC SIDE AND RE-RAN PREVIOUS SAMPLES. THE CUSTOMER STATED THAT THE DOCUMENTED DXC 600PRO IS THEIR BACKUP ANALYZER AND VERY FEW SAMPLES WERE RUN PRIOR TO THE PROBLEM. THE CUSTOMER CHECKED THE SAMPLES AND INDICATED THAT TWO PATIENT RESULTS FOR HEMOGLOBIN A1C (HBA1C) WERE REPORTED OUT OF THE LABORATORY ERRONEOUSLY HIGH. PATIENT # 1 (PATIENT DEMOGRAPHICS PROVIDED IN THIS REPORT) FIRST RESULT WAS 39.2 G/DL AND THE CORRECTED RESULT WAS 7.5 G/DL. PATIENT # 2 (AGE - (B)(6), DOB - (B)(6) 1941, GENDER - MALE) WAS 28.7 G/DL AND THE CORRECTED RESULT WAS 4.5 G/DL. THE CUSTOMER DOESN'T KNOW IF PATIENT TREATMENT WAS AFFECTED. NO EXPOSURE OR INJURY OCCURRED DUE TO THE CONTAINED LEAK. THE OPERATOR IS NOT SEEKING ANY FORM OF MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194367 UNICEL® DXC 600 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR