BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2630332 · Received June 27, 2012

    Report

    Report Number
    2050012-2012-01349
    Event Type
    Malfunction
    Date Received
    June 27, 2012
    Date of Event
    June 4, 2012
    Report Date
    June 4, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MZV
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, CUSTOMER REPORTED THAT THE DXC 600 PRO GENERATED A FALSE HIGH POTASSIUM (K) RESULT OF 5.9 MMOL/L ON 1 PATIENT SAMPLE. THE RESULT WAS NOT REPORTED OUT OF THE LAB. CUSTOMER STATED THAT BECAUSE THE RESULT DID NOT MATCH PATIENT HISTORY, IT WAS REPEATED. CUSTOMER STATED THAT UPON REPEAT THE INSTRUMENT SUPPRESSED THE RESULT (DID NOT GENERATE A RESULT). AFTER TROUBLESHOOTING CORRECTED THE ISSUE, THE SAMPLE WAS RUN AGAIN WITH A RESULT OF 4.7 MMOL/L, AND THIS RESULT WAS REPORTED. CUSTOMER STATED THAT AT THE TIME OF THE EVENT, THE INSTRUMENT SUPPRESSED ALL THE OTHER ION SELECTIVE ELECTRODE (ISE) RESULTS FOR THIS PATIENT SAMPLE AND TWO OTHER PATIENT SAMPLES. CUSTOMER STATED THAT THE K RESULT WAS THE ONLY RESULT THAT PRINTED OUT A NUMERICAL VALUE. CUSTOMER STATED THAT QUALITY CONTROL (QC) PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES, BUT THE CUSTOMER DID NOT PROVIDE THE ACTUAL DATA. CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING, VIA PHONE. CUSTOMER STATED THAT THE ISE REFERENCE REAGENT WAS LOW, AND CTS INSTRUCTED THE CUSTOMER TO LOAD NEW ISE REFERENCE AND ISE BUFFER REAGENTS AND RECALIBRATE. CUSTOMER REPORTED THAT THIS ACTION RESOLVED THE ISSUE. NO FURTHER PROBLEMS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1