BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 PRO SYNCHRON SYSTEM

    MDR report key: 13105845 · Received December 29, 2021

    Report

    Report Number
    2050012-2021-00076
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    December 3, 2021
    Report Date
    December 29, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    15099590375034
    PMA / PMN Number
    K103842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND EVALUATED THE DEVICE. THE FSE REPLACED MULTIPLE HARDWARE COMPONENTS TO RESOLVE THE ISSUE. THE FOLLOWING COMPONENTS WERE REPLACED: SAMPLE PROBE (PART # 389375). DI WATER SENSOR ASSEMBLY (PART # 472958). SAMPLE SYRINGE 100 UL (PART # B06040), REAGENT SYRINGE (PART # 474172). T-VALVE (PART # 758419), HAMILTON VALVE (HV 4-4 VALVE: PART # 970835). MIXING PADDLE (PART # B53893). BECKMAN COULTER INTERNAL IDENTIFIER IS CASE: (B)(4). PATIENT DEMOGRAPHIC INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORT THE UNICEL DXC 600 PRO SYNCHRON SYSTEM GENERATED ERRONEOUS LOW AND SUPPRESSED (NO VALUE) PATIENT RESULTS FOR BUN (BLOOD UREA NITROGEN), CREA (CREATININE) AND TBIL (TOTAL BILIRUBIN). THE ERRONEOUS PATIENT RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE WAS NO CHANGE IN PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2006171 UNICEL DXC 600 PRO SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 600 PRO, UCTA & CTA READY, PACKAGED N/A 15099590375034

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown