BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXC 600 PRO

    MDR report key: 9153792 · Received October 3, 2019

    Report

    Report Number
    2050012-2019-01116
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    September 23, 2019
    Report Date
    October 3, 2019
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    15099590375034
    PMA / PMN Number
    K103842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNICEL® DXC 600 PRO INSTRUMENT, AND IDENTIFIED THE FAILURE MODE AS MULTIPLE HARDWARE. THE FSE REPLACED THE SAMPLE PROBE, VACUUM WASH COLLAR WASTE VALVE AND THE WASH COLLAR VALVE FOR REAGENT PROBES A AND B TO RESOLVE THE ISSUE. INFORMATION NOT PROVIDED BY CUSTOMER. THE BECKMAN COULTER INTERNAL IDENTIFIER IS CASE-(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE GENERATION OF MULTIPLE ERRONEOUS PATIENT RESULTS FOR MULTIPLE CHEMISTRIES ON CC (CARTRIDGE CHEMISTRY SIDE) WITH ORR LO ERROR AND MC (MODULAR CHEMISTRY) AND CC (CLINICAL CHEMISTRY) PROBE OBSTRUCTION ERRORS ON THEIR UNICEL® DXC 600 PRO INSTRUMENT. THE ERRONEOUS PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY AND WERE LATER AMENDED. THERE WAS NO AFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. QUALITY CONTROL WAS WITHIN THE LABORATORY¿S ESTABLISHED RANGES PRIOR TO EVENT. THE CUSTOMER DID NOT PROVIDE DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946825 DXC 600 PRO ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 600 PRO, UCTA & CTA READY, PACKAGED 15099590375034

    Patients

    Seq Age Sex Outcome Treatment
    1