BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2083754 · Received May 10, 2011

    Report

    Report Number
    2050012-2011-01598
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CO2 QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. CO2 QC AFTER THE EVENT WAS OUT OF RANGE LOW. AFTER RECALIBRATION ON (B)(4) 2011, INSTRUMENT PERFORMED ACCEPTABLY AND NO FURTHER CO2 ISSUES WERE NOTED. BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 04/19/11. FSE PERFORMED SYSTEM HEALTH CHECKS. BCI TECHNICAL SUPPORT REVIEWED CUSTOMER'S DATA AND DETERMINED ALL VALUES MEET THE ION SELECTIVE ELECTRODE (ISE) MOD PERFORMANCE CRITERIA. FURTHER REVIEW OF DATA SHOWS THAT DURING THE TIME FRAME OF EVENT, THE INSTRUMENT WAS GENERATING SAMPLE PROBE OBSTRUCTION ERRORS. CUSTOMER RECALIBRATED THE ISE'S AND QC RECOVERED PROPERLY. BCI TECHNICAL SUPPORT REVIEWED THE ISE CALIBRATIONS AND QC, POST CUSTOMER RECALIBRATION, AND NO FURTHER ISSUES WERE NOTED. ROOT CAUSE IS BELIEVED TO BE A SAMPLE HANDLING ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT FALSE LOW CO2 RESULTS,GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER, FOR THIRTY FIVE (35) PATIENTS. SOME RESULTS WERE REPORTED OUT OF THE LAB. WHEN ISSUE WAS NOTICED, SAMPLES WERE RETESTED ON AN ALTERNATE INSTRUMENT. RESULTS THAT WERE ERRONEOUSLY REPORTED WERE AMENDED. IT IS UNKNOWN IF TREATMENT WAS INITIATED OR WITHHELD BASED ON THE FALSE CO2 RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1