BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 660I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 3033969 · Received April 3, 2013

    Report

    Report Number
    2050012-2013-00236
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE UNICEL DXC 660I SYNCHRON ACCESS CLINICAL SYSTEM GENERATED QUALITY CONTROL RESULTS OUTSIDE THE LABORATORY'S ESTABLISHED RANGES. WHILE TROUBLESHOOTING, THE CUSTOMER FOUND THAT THE INSTRUMENT LEAKED FLUID ONTO THE DRIP TRAY ON TOP OF THE REAGENT CAROUSEL AND ON APPROXIMATELY 80% OF THE REAGENT CARTRIDGES IN THE REAGENT COMPARTMENT. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT AT THE TIME OF THE INCIDENT. THERE WAS NO REPORT OF INJURY OR EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES, AND MEDICAL ATTENTION WAS NOT SOUGHT. THE CUSTOMER DID NOT REVIEW THE MATERIAL SAFETY DATA SHEET (MSDS), BUT HAS AN EXPOSURE CONTROL PLAN IN PLACE AT THE FACILITY. THERE WAS NO IMPACT TO PATIENT RESULTS OR TREATMENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) FOUND THAT THE REAGENT PROBE B WAS LEAKING DEIONIZED WATER. THE FSE REVIEWED THE INSTRUMENT EVENT LOG AND FOUND THAT THE INSTRUMENT GENERATED SEVERAL ERROR MESSAGES. ALTHOUGH THE OPERATOR WAS ALERTED TO A PROBLEM VIA ERROR MESSAGES AND THE INSTRUMENT STOPPED GENERATING RESULTS, THE ERROR MESSAGES WERE FOR MOTION ERRORS AND WERE NOT RELATED TO THE LIQUID LEAKING FROM THE REAGENT PROBE B COLLAR WASH. THE ERROR MESSAGES WOULD NOT ALERT THE OPERATOR THAT LIQUID LEAKED INTO THE REAGENT COMPARTMENT, POTENTIALLY CONTAMINATING THE REAGENTS. UPON FURTHER INVESTIGATION THE FSE FOUND THAT THE SMART MODULE C3 WAS NOT FUNCTIONING PROPERLY. THE FSE NOTED THAT THE SMART MODULE C3 FAILURE RESULTED IN A CASCADE OF FAILURES, INCLUDING THE REAGENT PROBE B COLLAR WASH VALVE WHICH WAS STUCK AND NOT VACUUMING FLUID AWAY FROM REAGENT PROBE B. AS A RESULT, FLUID LEAKED INTO THE REAGENT COMPARTMENT AND ONTO MOST OF THE REAGENT CARTRIDGES. THE FSE REPLACED THE SMART MODULE C3, AND VERIFIED THE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137229 UNICEL® DXC 660I SYNCHRON® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 660I NA

    Patients

    Seq Age Sex Outcome Treatment
    1