BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3233038 · Received July 18, 2013

    Report

    Report Number
    2050012-2013-00494
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THAT THE CUSTOMER HAD REPLACED THE IRON REAGENT CALIBRATOR AND REAGENT BUT STILL RECEIVED CALIBRATION FAILURES. SERVICE WAS DISPATCHED. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE FOUND NO EVIDENCE OF A LEAK IN THE REAGENT CAROUSEL. FSE STATES THE LEAK WAS CONDENSATION. THE FSE DID CONFIRM THAT IRON WAS FAILING CALIBRATION AND QUALITY CONTROL (QC). THE FSE RAN A PVT3 TEST EVALUATE SAMPLE PROBE CARRYOVER WHICH FAILED. THE FSE REPLACED MULTIPLE HARDWARE COMPONENTS WHICH INCLUDE THE FOLLOWING: SAMPLE PROBE, WASH COLLAR, AND MIXER. THE FSE ALSO PERFORMED ROTARY ALIGNMENTS AFTER REPLACEMENTS. AFTER REPLACING MULTIPLE HARDWARE COMPONENTS, THE FSE RERAN THE PVT3 TEST WITH PASSING RESULTS. THE FSE ALSO RECALIBRATED THE IRON MODULE AND RAN QC WHICH WAS WITHIN THE CONTROL RANGE. MULTIPLE HARDWARE COMPONENTS ASSOCIATED WITH THE SAMPLE HANDLING SYSTEM WERE REPLACED, ANY OF WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING BACK-TO-BACK CALIBRATION FAILURES FOR IRON (FE) SINCE (B)(6) 2013 AND A LEAK COMING FROM THE CARTRIDGE CHEMISTRY (CC) REAGENT CAROUSEL IN THE UNICEL DXC 660I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER OBSERVED APPROXIMATELY 2 MLS OF FLUID IN THE CC REAGENT CAROUSEL. THE CUSTOMER WAS UNABLE TO IDENTIFY THE MATERIAL THAT LEAKED OUT OF THE INSTRUMENT, BUT THE CUSTOMER MENTIONED THAT THE FLUID SMELLED LIKE SULFUR. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT DURING THIS EVENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. THE CUSTOMER CONFIRMED THAT NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT. ACCORDING TO THE DXC IFU MANUAL, "THE BACK-TO-BACK ERROR CHECK IS A MEASURE OF SYSTEM PRECISION DURING CALIBRATION. A BACK-TO BACK VALUE IS THE DIFFERENCE BETWEEN THE TWO MIDDLE SAMPLE REFERENCE REPLICATE VALUES WITHIN A CALIBRATION LEVEL. IF THE BACK-TO-BACK LIMIT IS EXCEEDED THE CALIBRATION FAILS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334551 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