BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1901296 · Received November 17, 2010

    Report

    Report Number
    2050012-2010-01311
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM IS ROUTINELY CALIBRATED EVERY 24 HOURS AND QC IS ALSO RUN EVERY 24 HOURS. QC RESULTS PRIOR TO THE EVENT WERE WITHIN THE ESTABLISHED RANGES. THE CUSTOMER RUNS A REPORT ON SODIUM RESULTS EVERY 4 HOURS AND DETECTED A TREND OF LOW PATIENT RESULTS. ON (B)(6) 2010, A BCI ENGINEER CLEANED THE FLOW CELL, CHANGED THE CHLORIDE TIP, CHANGED THE QUAD RINGS AND REBUILT THE RATIO PUMP. AS OF (B)(6) 2010, THERE WERE NO FURTHER CALLS TO HOTLINE FOR THE PROBLEMS. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. THE FOLLOWING MEDWATCH REPORT NUMBERS ARE LINKED TO THIS EVENT: 2050012-2010-01079; 2050012-2010-01298; 2050012-2010-01299; 2050012-2010-01300; 2050012-2010-01301; 2050012-2010-01302; 2050012-2010-01303; 2050012-2010-01304; 2050012-2010-01305; 2050012-2010-01306; 2050012-2010-01307; 2050012-2010-01308; 2050012-2010-01309; 2050012-2010-01310.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO 14 ERRONEOUSLY LOW SODIUM (NA) RESULTS GENERATED BY UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. WHEN REPEATED, THE NA RESULTS WERE HIGHER. THE RESULTS FOR PATIENT 14 ARE SHOWN. THE CUSTOMER HAS NOT RECEIVED ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1