BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2111739 · Received June 2, 2011

    Report

    Report Number
    2050012-2011-02112
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, THEY HAVE HAD TG SUPPRESSION ISSUES IN THE PAST, AND THEIR FIELD SERVICE ENGINEER (FSE) HAS RECENTLY REPLACED THE ENTIRE WASH TOWER. BCI CUSTOMER TECHNICAL SUPPORT (CTS) HELPED THE CUSTOMER TROUBLESHOOT THE HARDWARE (CLEAN THE CARTRIDGE CHEMISTRY SAMPLE PROBE AND COLLAR WASHER, REPLACE THE REAGENT MIXER PADDLE AND THE SYRINGE PLUNGER RODS). CTS FOUND THE CUSTOMER HAD PUSHED THE WIPER UP TOO FAR UP AGAINST THE PHYSICAL STOP ON THE PROBE. THE CUSTOMER WAS INFORMED THAT THE WIPER SHOULD BE FLUSH WITH THE TIP OF THE PROBE. FIELD SERVICE ENGINEER (FSE) VISITED THE SITE 3 TIMES, PERFORMED TROUBLESHOOTING, REPLACED HARDWARE AS NECESSARY AND PERFORMED SEVERAL REPAIRS. ON THE THIRD VISIT, (B)(4)-2011 FSE REPLACED WASH VACUUM PROBES. REPLACED REAGENT PROBE A WASH COLLAR AND PERFORMED ALIGNMENTS. RAN ALL PVTS WITH NO FAILURES, RAN REAGENT PROBE CARRYOVER 4 TIMES WITH NO FAILURES. THE REPAIRS PERFORMED BY THE FSE RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING HIGH RESULTS FOR TRIGLYCERIDES (TG) GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE FALSE HIGH RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. TG WAS 297MG/DL AND UPON RERUN ON OTHER ANALYZER WAS 124MG/DL. THE CUSTOMER DID NOT REPORT ANY DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1