BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2242270 · Received September 9, 2011

    Report

    Report Number
    2050012-2011-05124
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE TO ADDRESS THIS ISSUE. BECKMAN COULTER INC. GUIDED INSTRUMENT TROUBLESHOOTING INVOLVED PERFORMANCE ASSESSMENTS, VISUAL EVALUATION AND HARDWARE CORRECTIONS. THESE ACTIVITIES RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B)(6) 2011, ERRONEOUSLY CHLORIDE RESULTS WERE GENERATED FROM A UNICEL DXC 600 SYNCHRON SYSTEM FOR MULTIPLE PATIENT SAMPLES. BECKMAN COULTER INC. EVALUATION OF CUSTOMER SUPPLIED DATA CLARIFIED THE EVENT TO THE GENERATION OF ERRONEOUS SODIUM (NA), POTASSIUM (K), CL AND/OR CALCIUM (CALC) FOR THREE PATIENTS. THE INITIAL ASSAY RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY HOWEVER THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. INSTRUMENT SODIUM QUALITY ASSURANCE RESULTS WERE LOW PRIOR TO THIS EVENT. CHLORIDE AND CALCIUM QUALITY ASSURANCE RESULTS WERE BELOW CUSTOMER'S ESTABLISHED SPECIFICATIONS AFTER THE EVENT. BECKMAN COULTER INC. LED THE CUSTOMER THROUGH INSTRUMENT TROUBLESHOOTING. THE CUSTOMER CLEANED THE CHLORIDE ELECTRODE AND PORT, RECALIBRATE THE INSTRUMENT AND ASSESSED THE SODIUM REFERENCE ELECTRODE FOR BUBBLES. THESE ACTIONS RESOLVED THE ISSUE. THE ERRONEOUS INITIAL RESULTS WERE CAUSED BY THE SAME INSTRUMENT MALFUNCTION(S). AFTER INSTRUMENT TROUBLESHOOTING, REPEAT RESULTS WERE GENERATED, REGARDED AS VALID AND PATIENT REPORTS WERE AMENDED. PATIENT SPECIFIC INFORMATION AND SAMPLE COLLECTION/HANDLING INFORMATION WERE NOT 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