BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 3223227 · Received July 12, 2013

    Report

    Report Number
    2050012-2013-00451
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND REPLACED THE CC (CARTRIDGE CHEMISTRY) SAMPLE SYRINGE AND T-VALVE TO OBSTRUCTION DETECTION COMPONENT AND TO THE PROBE. THE FSE ALSO REPLACED THE DEGASSER TO RESOLVE THE ISSUE. RESULTS: FAILURE MODE OF THE EVENT IS UNKNOWN AS MULTIPLE PARTS WERE REPLACED ON THE CC SIDE OF THE INSTRUMENT TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT OBTAINING ERRONEOUSLY HIGH ALT (ALANINE AMINOTRANSFERASE) RESULTS FOR FIVE (5) SAMPLES UPON RERUNNING FOUR HUNDRED AND SEVEN (407) PATIENT SAMPLES FROM THE UNICEL DXC 600 SYNCHRON SYSTEM. THE CUSTOMER STATED THAT RESULTS WERE AMENDED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER ONLY PROVIDED ONE PATIENT RESULTS OUT OF THE FIVE PATIENTS WHO WERE ALLEGEDLY AFFECTED. THE CUSTOMER WOULD NOT PROVIDE DATA FOR THE OTHER FOUR PATIENT SAMPLES. ALT QC (QUALITY CONTROL) RESULTS PRIOR TO THE EVENT WERE WITHIN THE LABORATORY'S ESTABLISHED RANGES AND CLOSE TO THE MEAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321576 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1