BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2022831 · Received March 17, 2011

    Report

    Report Number
    2050012-2011-00732
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 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

    THE SAMPLES ARE COLLECTED IN CLOSED, PIERCED CAP TUBES WITH THE SUFFICIENT SAMPLE VOLUME POURED INTO NESTING CUPS. NO PROBLEMS WERE NOTED WITH CALIBRATION OR QC PRIOR TO OR AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND REPORTED THAT THE COLLAR WASH WAS LOOSE AND SUSPECTS THE LEVEL SENSING IS NOT WORKING PROPERLY. THE FSE ALSO INDICATED THAT WHEN THE LEVEL SENSE CABLE WAS BENT TO THE LEFT, A FALSE LEVEL SENSE MESSAGE WAS OBTAINED DURING TROUBLESHOOTING. THE FSE REPLACED THE PROBE/LEVEL SENSE. ALTHOUGH HARDWARE WAS REPLACED, THE ROOT CAUSE REMAINS UNKNOWN TO DATE.

    Description of Event or Problem · 1

    BECKMAN COULTER INC., (BCI) CONTACTED THIS CUSTOMER VIA THE BCI INTERNAL MONITORING DATA FOR GLUCOSE MODULE (GLUCM) PHASE I CUSTOMER CONTACT PROGRAM. THE CUSTOMER INDICATED ONE (1) PATIENTS' GLUCM SAMPLE RESULT DID NOT MATCH WHEN RUNNING IN DUPLICATE MODE. THE SAMPLE GENERATED A FALSE LOW RESULT. IT IS UNKNOWN WHAT RESULT WAS REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT CALL AND COMPLAIN TO BCI ABOUT THIS SAMPLE. PATIENT TREATMENT WAS NOT AFFECTED IN REGARD TO THIS EVENT AS THE CUSTOMER RUNS GLUCOSE IN DUPLICATE MODE AND VERIFIES PRIOR TO REPORTING RESULTS.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1