BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 3131888 · Received May 29, 2013

    Report

    Report Number
    2050012-2013-00363
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL (QC) TBIL RESULTS WERE WITHIN 2 STANDARD DEVIATION (SD) RANGE BEFORE AND AFTER THE EVENT. BEC CUSTOMER TECHNICAL SUPPORT (CTS) HAD THE CUSTOMER CHECK THE FITTINGS OF THE SAMPLE AND REAGENT SYRINGES, AND THE MIXERS FOR SCRATCHES, DENTS, BENT OR WORN MIXERS AND CHECK THE WASH STATION AND THE WIPER. NO ISSUES WERE FOUND WITH THESE COMPONENTS. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2013 FOR THIS EVENT. THE FSE PERFORMED A PREVENTIVE MAINTENANCE (PM) PROCEDURE ON THE CARTRIDGE CHEMISTRY SAMPLE AND REAGENT HANDLING. THE PM INCLUDED REPLACING MULTIPLE CARTRIDGE CHEMISTRY SAMPLE AND REAGENT HANDLING COMPONENTS, WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER GENERATED FALSELY LOW TOTAL BILIRUBIN (TBIL) RESULTS THAT WERE "NORMAL" UPON REPEAT. THE CUSTOMER INDICATED THE INCORRECT RESULTS HAD BEEN 0.0, 0.1 OR 0.2 MG/DL, AND ABOUT A DOZEN SAMPLES WERE AFFECTED. THE CUSTOMER CONFIRMED THAT NO INCORRECT RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT INDICATE THAT ANY OTHER CHEMISTRY RESULTS WERE AFFECTED, AND DID NOT REPORT ANY SYSTEM ERROR MESSAGES THAT WERE GENERATED. THE CUSTOMER STATED THAT "NORMAL" RESULTS WOULD BE BETWEEN 0.3 AND 1.2 MG/DL AND DEPENDING UPON THE RESULT, COULD BE DISCREPANT PER 2 STANDARD DEVIATION (SD) TOTAL PRECISION SPECIFICATIONS. THERE WAS NO IMPACT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235247 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1