BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2983104 · Received February 28, 2013

    Report

    Report Number
    2050012-2013-00112
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 20, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER IS PROVIDING AN ADDTIONAL INFORMATION FOR MDR #: 2050012-2013-00112, (B)(4). INVESTIGATION INFORMATION: THE RATIO PUMP WAS RETURNED TO BECKMAN COULTER FOR INVESTIGATION. TESTING OF THE RETURNED PART DID NOT DUPLICATE THE ISSUE; THE RETURNED PART PERFORMED WITHIN SPECIFICATIONS. ALL THE REMAINING INFORMATION IN THE ORIGINAL REPORT REMAINS UNCHANGED.

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE CHANGED BOTH NA ELECTRODES AND CLEANED THE FLOWCELL AND THE ELECTROLYTE INJECTION CUP (EIC). THE FSE REPLACED THE EIC SPACER AND QUAD RING. THE FSE ALSO REPLACED THE RATIO PUMP WHICH WAS NOT SCHEDULED FOR REPLACEMENT UNTIL (B)(4) 2013. ADDITIONALLY, FSE CHANGED THE CARBON DIXIDE (CO2) MEMBRANE. FAILURE MODE OF THIS EVENT WAS NOT DETERMINED. MULTIPLE PARTS WERE REPLACED, ANY OF WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ON (B)(6) 2013, THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM GENERATED FALSE HIGH SODIUM (NA) AND POTASSIUM (K) RESULTS FOR 2 PATIENT SAMPLES. THE HIGH RESULTS WERE REPORTED OUT OF THE LABORATORY. CUSTOMER PROVIDED ALL RESULTS, BUT ONLY NA AND K RESULTS WERE ERRONEOUS. QC ON THE DAY OF THE EVENT SHOWED IMPRECISION AND HIGH RECOVERY, BUT WAS REPEATED AND RESULTS OBTAINED WERE WITHIN RANGE. PATIENT TREATMENT WAS NOT AFFECTED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85934 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 600I

    Patients

    Seq Age Sex Outcome Treatment
    1