BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1964351 · Received January 19, 2011

    Report

    Report Number
    2050012-2011-00181
    Date Received
    January 19, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPLACED THE AQUACALS WITH FRESH SAMPLES AND OBTAINED HIGHER SODIUM AND CHLORIDE RESULTS. ON (B)(4) 2010 BCI FIELD SERVICE ENGINEER (FSE) INSPECTED THE ION-SELECTIVE ELECTRODE (ISE) MODULE AND CURRENT CALIBRATION REPORT. NO ISSUES WERE REPORTED AND NO VISUAL SIGNS OF CONTAMINATION WERE NOTED. FSE RAN 10% NAOCL FROM THE REAGENT STRAW AND RAN ISE HEALTH CHECK SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPLACED THE AQUACALS WITH FRESH SAMPLES AND OBTAINED HIGHER SODIUM AND CHLORIDE RESULTS. ON (B)(4) 2010, BCI FIELD SERVICE ENGINEER (FSE) INSPECTED THE ION-SELECTIVE ELECTRODE (ISE) MODULE AND CURRENT CALIBRATION REPORT. NO ISSUES WERE REPORTED AND NO VISUAL SIGNS OF CONTAMINATION WERE NOTED. FSE RAN 10% NAOCL FROM THE REAGENT STRAW AND RAN ISE HEALTH CHECK SUCCESSFULLY. CORRECTION IN SERIAL NUMBER FROM (B)(4) TO (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO INTERMITTENT LOW ANION GAPS ON THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED USING A FRESH AQUACALS AND THE HIGHER RESULTS WERE OBTAINED. THE CUSTOMER PROVIDED TWO EXAMPLES OF PATIENT RESULTS WHICH ARE SHOWN. PATIENTS TREATMENT WAS NOT IMPACTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO INTERMITTENT LOW ANION GAPS ON THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED USING A FRESH AQUACALS AND THE HIGHER RESULTS WERE OBTAINED. THE CUSTOMER PROVIDED TWO EXAMPLES OF PATIENT RESULTS WHICH ARE SHOWN. PATIENTS TREATMENT WAS NOT IMPACTED.

    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