BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 PRO INSTRUMENT

    MDR report key: 2101879 · Received April 29, 2011

    Report

    Report Number
    2050012-2011-01329
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    May 7, 2009
    Report Date
    May 8, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GLUCOSE SENSING ELECTRODE IN USE AT THE TIME OF EVENT FROM THE DEVICE WAS RETURNED BY THE CUSTOMER AND INVESTIGATED AS PART OF AN INTERNAL CAPA INVESTIGATION. NO DEVICE EVALUATION RESULTS WERE OBTAINED. USE ERROR CONTRIBUTED TO THE EVENT. THE CUSTOMER ADVISED THAT PRE-RUN TEST INDICATED AN ERROR. THE CUSTOMER CONTINUED TO PROCESS SAMPLES IN LIGHT OF THE REPORTED ERRORS. TWO ADDITIONAL QC RUNS FOLLOWING THE SAMPLES INDICATED FAILED CALIBRATION. THIS IS ONE OF 28 REPORTS RELATED TO 28 PATIENT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. SEE MDR REPORT NUMBERS FOR ALL EVENTS: 2050012-2011-01326, 01327, 01328, 01330, 01331, 01332, 01333, 01334, 01335, 01336, 01337, 01338, 01339, 01340, 01341, 01342, 01343, 01344, 01345, 01346, 01347, 01348, 01349, 01350, 01351, 01352, 01353. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY WERE RECEIVING INITIAL RATE LOW (IL) ERRORS ON QC. THE SYSTEM QC REPORT RETURNED ERRORS AND FAILED CALIBRATION PRIOR TO RUNNING PATIENT SAMPLES. THE USER CONTINUED TO PROCESS PATIENT SAMPLES. APPROXIMATELY 25 GLUCOSE CUP PATIENT RESULTS WERE REPORTED ERRONEOUSLY LOW. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. CUSTOMER THEN RAN QC SAMPLES WHICH WERE OUT OF RANGE. THE CUSTOMER THEN RERAN THE 25 SAMPLES ON ANOTHER SYSTEM AND OBTAINED RESULTS THAT WERE WITHIN AN ACCEPTABLE RANGE. CUSTOMER REPLACED THE GLUCOSE ELECTRODE AND NO FURTHER EVENTS WERE REPORTED. THE CORRECTED GLUCOSE RESULTS WERE REPORTED. THERE IS NO INDICATION OF ANY ADVERSE PATIENT CONSEQUENCE AND IT IS NOT KNOWN IF ANY CHANGES WERE MADE TO THE PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 PRO INSTRUMENT JJE BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR