BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2055170 · Received April 14, 2011

    Report

    Report Number
    2050012-2011-00961
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO THE EVENT, THE LAB HAD REPLACED THE MC SAMPLE SYRINGE. SUBSEQUENT CALIBRATIONS FAILED. ADDITIONAL MAINTENANCE (FLOW CELL CLEANING) WAS PERFORMED, BUT THERE WERE STILL PROBLEMS CALIBRATING. WHEN THE TREND LOW WAS NOTICED IN PATIENT RESULTS, QC WAS RERUN AND WAS LOW. THE MC SYRINGE WAS RE-CHECKED AND SUSPECTED AS THE CAUSE OF THE ISSUE. THE OLD PLUNGER WAS RE-INSTALLED. CALIBRATIONS AND QC PASSED AND PATIENT SAMPLES WERE RERUN. SINCE SERVICE WAS NOT INITIATED, THE CUSTOMER SENT PERFORMANCE TESTING RESULTS TO BCI. TECH SUPPORT REVIEWED THE DATA AND VERIFIED THAT TESTING PASSED SPECIFICATIONS. HOTLINE SENT THE CUSTOMER A REPLACEMENT SYRINGE AND HAD THE CUSTOMER INSTALL THE NEW SYRINGE. AS OF (B)(4) 2011, NO FURTHER ISSUES HAVE BEEN NOTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSE SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), CARBON DIOXIDE (CO2), CALCIUM (CALC), AND GLUCOSE (GLUCM) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM FOR MULTIPLE PATIENT SAMPLES. THE RESULTS WERE REPORTED OUT OF THE LAB. AFTER TROUBLESHOOTING RESOLVED THE ISSUE, THE SYSTEM WAS RECALIBRATED AND SAMPLES RERUN. CORRECTED REPORTS WERE ISSUED. PATIENT TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE FALSE RESULTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1