BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2302201 · Received October 20, 2011

    Report

    Report Number
    2050012-2011-06288
    Event Type
    Malfunction
    Date Received
    October 20, 2011
    Date of Event
    September 22, 2011
    Report Date
    September 22, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE CALIBRATION FOR ACETAMINOPHEN (ACTM), GENTAMICIN (GEN), AND THEOPHYLLINE (THE) WAS FAILING WITH SPAN AND RECOVERY ERRORS ON THE UNICEL DXC 600 SYNCHRON SYSTEM. THE CUSTOMER REPORTED THAT HE HAD CHANGED THE 100 MICROLITRE SAMPLE SYRINGE ASSEMBLY EARLIER DURING THE DAY. CUSTOMER REPORTED HE WAS NOT AWARE OF ANY ERRONEOUS PATIENT RESULTS GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC CUSTOMER TECHNICAL SPECIALIST (CTS) ADVISED THE CUSTOMER TO VERIFY ALL SYRINGES WERE INSTALLED PROPERLY, AND THAT ALL FITTINGS ON TOP OF THE PROBES WERE TIGHT. THE CUSTOMER THEN REPORTED THAT HE SAW A COLORLESS FLUID ON TOP OF THE REACTION WHEEL COVER BY THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE AREA. THE CUSTOMER WAS ADVISED TO PRIME THE CC SAMPLE DELIVERY SYSTEM AND OBSERVE FOR LEAKS. CUSTOMER REPORTED THAT THERE WERE NO LEAKS AFTER PRIMING THE CC SAMPLE DELIVERY SYSTEM. CUSTOMER REPORTED THAT THEY CALIBRATED ACTM, GEN, AND THE WITHOUT ANY ADDITIONAL PROBLEMS AFTER PRIMING THE CC SAMPLE DELIVERY SYSTEM. TO DATE, CUSTOMER HAS NOT REPORTED TO BEC ON ANY FURTHER LEAKING OR CALIBRATION ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1