BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2500645 · Received March 22, 2012

    Report

    Report Number
    2050012-2012-00776
    Event Type
    Malfunction
    Date Received
    March 22, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE TO ADDRESS THIS EVENT AS IT WAS RESOLVED BY BECKMAN COULTER INC. LED CUSTOMER TROUBLESHOOTING. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED ANALYTE INSTRUMENT PERFORMANCE DATA INDICATED THAT QUALITY CONTROL AND CALIBRATION RESULTS APPEARED TO BE ACCEPTABLE. BECKMAN COULTER INC. CUSTOMER TECHNICAL SPECIALIST (CTS) INSTRUCTED THE CUSTOMER TO STOP THE INSTRUMENT AND FLUSH BOTH THE CARTRIDGE CHEMISTRY REAGENT PROBES AND THE SAMPLE PROBE. CUSTOMER TECHNICAL SPECIALIST INSTRUCTED THE CUSTOMER TO INSPECT BOTH MIXER PADDLES AND REPLACE IF SCRATCH OR BENT. CUSTOMER TECHNICAL SPECIALIST INSTRUCTED CUSTOMER TO WASH ALL CUVETTES. ROOT CAUSE IS NOT KNOWN BUT HARDWARE REPAIRS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SUPPRESSED TRIGLYCERIDE (TG) RESULTS WITH INSTRUMENT GENERATED FLAGS WERE GENERATED ON AN UNICEL DXC 600 SYNCHRON SYSTEM FOR MULTIPLE PATIENT SAMPLES OVER AN UNDISCLOSED NUMBER OF DAYS. UPON REPEAT, THE SAMPLES GENERATED VALID NUMERICAL RESULTS. THE CUSTOMER INDICATED THAT THE SUPPRESSED TG RESULTS OCCURRED ON AT LEAST TWO DAYS, HOWEVER ACTUAL PATIENT RESULT OR DATES INVOLVED WERE NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER COULD NOT PROVIDE THE EXACT ERROR CODE ASSOCIATED WITH THE SUPPRESSED TG RESULTS. THE SUPPRESSED TG PATIENT RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND HENCE THERE HAVE BEEN NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE CUSTOMER DID NOT PROVIDE SPECIFIC PATIENT RESULTS OR SAMPLE COLLECTION/HANDLING INFORMATION.

    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