BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 3093213 · Received May 5, 2013

    Report

    Report Number
    2050012-2013-00301
    Event Type
    Malfunction
    Date Received
    May 5, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) VISITED THE CUSTOMER'S LABORATORY MULTIPLE TIMES AND REPLACED MULTIPLE PARTS INVOLVED IN SAMPLE HANDLING. THE FSE NOTED ISSUES WITH SLIGHT OBSTRUCTION IN CC SAMPLE PROBE CAUSING RANDOM SHORT SAMPLES, CC SAMPLE MOTION ERRORS, AND INTERMITTENT LOW SAMPLE VOLUME DRAWN BY CC SYRINGE ON THE INSTRUMENT. THE FSE REPLACED BOTH THE CC SAMPLE PROBE AND AUTOGLOSS WICK ON (B)(4) 2013 BUT THE ISSUE WAS NOT RESOLVED. THE FSE RETURNED THE FOLLOWING DAY ON (B)(4) 2013 TO REPLACE THE CC SAMPLE SYRINGE DRIVE ASSEMBLY AND PERFORMED ALIGNMENTS. FAILURE MODE IS ATTRIBUTED TO THE CC SYRINGE DRIVE THAT THE FSE REPLACED ON (B)(4) 2013. RESULTS: CC SYRINGE DRIVE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING SUPPRESSED (NON-NUMERIC), OUT OF INSTRUMENT RANGE LOW (OIR LO), CC (CARTRIDGE CHEMISTRIES) RESULTS FOR SEVERAL SAMPLES INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER PROVIDED RESULT PRINTOUTS FOR FOUR (4) PATIENTS. THE CUSTOMER DID NOT REPORT THE INCORRECT RESULTS OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER DISCOVERED THAT THE CC SAMPLE SYRINGE WAS LOOSE BUT TIGHTENING THE CC SAMPLE SYRINGE DID NOT RESOLVE THE ISSUE. THE CUSTOMER STATED THAT QC (QUALITY CONTROL) RESULTS WERE WITHIN SPECIFICATIONS BEFORE AND AFTER THE EVENT BUT DID NOT PROVIDE QC DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195937 UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1