BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2940425 · Received February 3, 2013

    Report

    Report Number
    2050012-2013-00060
    Event Type
    Malfunction
    Date Received
    February 3, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K04229121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ISSUE WAS RESOLVED BY THE CUSTOMER BY REPLACING THE ELECTRODE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY LOW NA (SODIUM) RESULTS FOR MULTIPLE PATIENTS INVOLVING A UNICEL DXC 600 SYNCHRON SYSTEM. THE CUSTOMER STATED THAT RERUNS PRODUCED NA RESULTS WHICH MATCH THE HISTORICAL RESULTS OF THE PATIENTS AND THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN TESTS DATA BUT THE CUSTOMER DID NOT REMEMBER THE DETAILS AND DID NOT PROVIDE THE DATA. THE CUSTOMER STATED THAT QUALITY CONTROL WAS RUN PRIOR TO THE EVENT BUT DID NOT INDICATE WHETHER THE QC RESULTS WERE WITHIN THE LABORATORY'S ESTABLISHED RANGES. THE CUSTOMER PROCEEDED TO REPLACE THE NA AND CL (CHLORIDE) ELECTRODES WHICH RESOLVED THE ISSUE. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED AND ISSUE WAS RESOLVED BY THE CUSTOMER. FAILURE MODE WAS DETERMINED TO BE THE NA ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45756 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1