BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2192225 · Received August 4, 2011

    Report

    Report Number
    2050012-2011-03928
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER FOUND THAT LINE 24 HAD COME OFF THE RATIO PUMP WHEN THE CUSTOMER PERFORMED MAINTENANCE. THE LINE WAS RE-INSTALLED AND INSTRUMENT PERFORMANCE WAS SUCCESSFULLY VERIFIED. THE INSTRUMENT WAS RETURNED INTO SERVICE AFTER COMPLETION OF REPAIRS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUS, ELEVATED POTASSIUM (K) RESULTS AND ERRONEOUS LOW CALCIUM (CALC) RESULTS WERE GENERATED ON A UNICEL DXC 600 SYNCHRON SYSTEM FOR TWO PATIENT SAMPLES. UPON REPEAT ON ANOTHER INSTRUMENT IN DUPLICATE, THE REPEAT RESULTS WERE REGARDED AS VALID AND REPORTED OUT OF THE LABORATORY. THE ERRONEOUS INITIAL RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND HENCE THERE WERE NO DEATHS, SERIOUS INJURIES OR CHANGES TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE INSTRUMENT DID NOT GENERATE SODIUM OR CARBON DIOXIDE RESULTS FOR THESE TWO SAMPLES. IT SUPPRESSED THEM. THESE PATIENTS' CHLORIDE RESULTS WERE NOT AFFECTED. INSTRUMENT ASSAY QUALITY CONTROL RESULTS GENERATED IMMEDIATELY PRIOR TO THIS EVENT WERE WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS. INSTRUMENT ASSAY QUALITY CONTROL RESULTS AFTER THE EVENT DEMONSTRATED THE SAME BEHAVIOR AS THE PATIENT SAMPLES. THE SAMPLES WERE SERUM OR PLASMA. NO ADDITIONAL SYSTEM, PATIENT OR SAMPLE HANDLING/COLLECTION INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1