BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 3112744 · Received May 14, 2013

    Report

    Report Number
    2050012-2013-00305
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED ON (B)(4) 2013 AND VISUALLY INSPECTED THE FLOWCELL ASSEMBLY BUT FOUND NO OBVIOUS ISSUES. THE FSE PROACTIVELY REPLACED THE FLOWCELL ASSEMBLY BUT THE HIGH ANION GAPS ISSUE PERSISTED AND THE FSE REPLACED THE RATIO PUMP. THE FSE RETURNED ON (B)(4) 2013 DUE TO CONTINUED IMPRECISION (BUT WITHIN THE ASSAY PRECISION CLAIMS) AND REPLACED THE ENTIRE ISE (ION SELECTIVE ELECTRODE) MODULE. PRECISION IMPROVED AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. RESULTS: FAILURE MODE IS UNKNOWN AS MULTIPLE PARTS WERE REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING HIGH ANION GAP RESULTS INVOLVING THE UNICEL DXC 800 SYNCHRON SYSTEM. ANION GAP IS A CALCULATION THAT ASSESSES THE VALIDITY OF THE NA (SODIUM), K (POTASSIUM), CL (CHLORIDE), AND CO2 (CARBON DIOXIDE) RESULTS AND IS NOT A DIAGNOSTIC TEST. THE CUSTOMER REPEATED THE SAMPLES WITH HIGH ANION GAPS ON A DIFFERENT ANALYZER AND RESULTS WERE REPORTED OUT OF THE LABORATORY. DATA REVIEW OF THE PROVIDED INSTRUMENT PRINTOUTS INDICATES THAT THE CUSTOMER HAD GENERATED AN ERRONEOUS CALC (CALCIUM) RESULT FOR ONE (1) PATIENT SAMPLE WHICH EXCEEDED THE ASSAY PRECISION CLAIM. THE CUSTOMER HAD ALSO OBTAINED ONE SUPPRESSED (NO VALUE GENERATED) CALC RESULT ON A DIFFERENT SAMPLE. NO DISCREPANT NA, K, CL, AND CO2 RESULTS WERE GENERATED AND THE DIFFERENCES BETWEEN THE ORIGINAL AND REPEAT RESULTS WERE WITHIN THE ASSAY PRECISION CLAIMS. THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. QC (QUALITY CONTROL) RESULTS AFTER THE CUSTOMER TROUBLESHOOT THE EVENT WERE WITHIN THE LABORATORY'S ESTABLISHED RANGES. THE CUSTOMER REPORTED THAT QC RESULTS PRIOR TO AND AFTER THE EVENT WERE OUT OF THE LABORATORY'S ESTABLISHED RANGES BUT NO DATA WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212226 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1