BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2395391 · Received January 3, 2012

    Report

    Report Number
    2050012-2011-08576
    Event Type
    Malfunction
    Date Received
    January 3, 2012
    Date of Event
    December 12, 2011
    Report Date
    December 12, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: PHOTOMETER LAMP ASSEMBLY. THIS REPORT IS ONE TWO REPORTS RELATED TO TWO EVENTS THAT OCCURRED ON TWO DIFFERENT DAYS. THIS REPORT IS RELATED TO MDR#2050012-2011-08575.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM (DXC 600I) GENERATED RANDOM SUPPRESSED RESULTS WITH "OIR LO" (OUT OF INSTRUMENT RANGE LOW) AND "BLANK RATE LOW" ERROR MESSAGES FOR CHEMISTRIES ON THE CARTRIDGE CHEMISTRY (CC) SIDE OF THE ANALYZER. CUSTOMER REPORTED THAT THE DXC 600I GENERATED SUPPRESSED RESULTS ON PATIENT AND QUALITY CONTROL (QC) SAMPLES. CUSTOMER REPORTED THAT THE TESTS AFFECTED INCLUDED CREATININE, LIPASE AND AMYLASE. CUSTOMER REPORTED THAT THEY HAD A LEAKING SYRINGE ISSUE AND SIMILAR SUPPRESSED RESULTS ERROR MESSAGES ON (B)(6), 2011. CUSTOMER REPORTED THAT THEY REPLACED THE SYRINGE PLUNGERS AND VERIFIED THERE WAS NO LEAK ON THE INSTRUMENT ON (B)(4), 2011. CUSTOMER REPORTED THAT THE SUPPRESSED RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC CUSTOMER TECHNICAL SUPPORT INSTRUCTED THE CUSTOMER TO FLUSH THE CC SAMPLE PROBE WITH 10% WASH SOLUTION. CUSTOMER REPORTED THAT AFTER PERFORMING THE FLUSH PROCEDURE, QC PASSED WITHOUT ANY ERROR MESSAGE. ON (B)(6), 2011, BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE T-VALVE, THE PHOTOMETER LAMP/SOURCE ASSEMBLY. THE FSE VERIFIED THE REPAIR WAS PERFORMED PER ESTABLISHED PROCEDURE. THE FSE VERIFIED THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1