BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2428200 · Received January 25, 2012

    Report

    Report Number
    2050012-2012-00244
    Event Type
    Malfunction
    Date Received
    January 25, 2012
    Date of Event
    January 2, 2012
    Report Date
    January 2, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LFG
    PMA / PMN Number
    K060256
    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 ON (B)(4) 2012 TO ADDRESS THIS ISSUE. THE FIELD SERVICE ENGINEER (FSE) FOUND MULTIPLE CUVETTES FAILING WATER BLANK. THE FSE REMOVED ALL CUVETTES AND MANUALLY CLEANED OUTSIDE OF THEM AND THEN PERFORMED A CUVETTE WASH FUNCTION. THE FSE CHECKED THE WASH/VACUUM PROBES FOR PROPER OPERATION AND ALIGNMENTS. THE FSE ALSO REPLACED A MIXER PADDLE AND SEVEN CUVETTES. THE FSE ADJUSTED THE PHOTOMETER DUE TO ELEVATED CUVETTE TRANSMITTANCE. UPON COMPLETION OF A LAMP ALIGNMENT, CUVETTE CENTERING, AND LAMP CALIBRATION, ALL THE CUVETTES HAD GOOD TRANSMITTANCE AND THE WATER BLANKS CLEARED UP. THE INSTRUMENT WAS RETURNED BACK INTO SERVICE. ROOT CAUSE IS NOT KNOWN BUT HARDWARE REPAIRS HAVE RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2012 ERRATIC VALPROIC ACID (VPA) RESULTS WERE GENERATED FROM A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT SAMPLE. THE SAME-SAMPLE VPA RESULTS TESTED ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM MULTIPLE TIMES, GENERATED VARYING RESULTS. THE SAMPLE WAS SUBSEQUENTLY TESTED ON ANOTHER INSTRUMENT WHICH GENERATED CONSISTENT VPA RESULTS WHICH WERE CONSIDERED VALID. THE INITIAL VPA RESULT WAS REPORTED OUT OF THE LABORATORY HOWEVER, THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. AN AMENDED REPORT WAS ISSUED. ASSAY QUALITY CONTROL (QC) RESULTS INDICATED THAT QC RESULTS MET CUSTOMER ESTABLISHED SPECIFICATION PRIOR TO THE EVENT, HOWEVER AN ELEVATED (FOUR STANDARD DEVIATIONS ABOVE MEAN VALUE) QC RESULT WAS GENERATED AFTER THE EVENT. THE SAMPLE WAS A SERUM SAMPLE THE CUSTOMER INDICATED THAT A "CUVETTE NOT DRY AT REAGENT DISPENSE" ERROR WAS GENERATED ON THE DAY OF THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1