BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2993672 · Received March 7, 2013

    Report

    Report Number
    2050012-2013-00152
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 20, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED QUALITY CONTROL (QC) WAS FAILING FOR SPECIFIC CHEMISTRIES ON (B)(6) 2013, BUT DID NOT PROVIDE DATA. THE SERVICE RECORD FOR THIS SYSTEM INDICATES CC CALIBRATION FAILURES AND QC IMPRECISION STARTING (B)(6) 2013 AND CONTINUING THROUGH (B)(6) 2013. CUSTOMER CONTACTED BEC SERVICE HOTLINE ON (B)(4) 2013 REGARDING MULTIPLE CHEMISTRIES FAILING CALIBRATION. BEC CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED CUSTOMER TRY CC PROBE CLEANING, THEN TRY CALIBRATION AGAIN. CUSTOMER CALLED BACK STATING THAT THE ISSUE WAS UNRESOLVED. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT TO INSPECT THE INSTRUMENT. THE FSE FOUND THAT THE REAGENT SYRINGE DRIVE (PART NUMBER (B)(4)) TO BE FAULTY. THE FSE OBSERVED THAT THE SYRINGE DRIVE WAS MOVING IMPROPERLY DURING REAGENT TRIGGER DRAW DUE TO ASSEMBLY ISSUE. THE PROBLEM WAS ABLE TO BE RESOLVED BY ADJUSTING A SCREW. VERIFIED PROPER MOTION, CALIBRATED AND RAN QC. FAILURE MODE IS RELATED TO HARDWARE; REPAIRS PERFORMED BY THE FSE RESOLVED THE ISSUE. THE FOLLOWING MDRS ARE RELATED TO THIS EVENT: 2050012-2013-00150, 2050012-2013-00151.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) IN REGARDS TO OBTAINING INCORRECT PATIENT RESULTS THAT WERE REPORTED OUT OF THE LABORATORY FOR MULTIPLE CARTRIDGE CHEMISTRIES (CC) FOR MULTIPLE PATIENT SAMPLES GENERATED ON THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THIS EVENT OCCURRED OVER THREE DAYS ((B)(6) 2013). THIS REPORT DOCUMENTS THE RESULTS OBTAINED ON (B)(6) 2013. THE LABORATORY DID NOT PROVIDE ANY PATIENT DETAILS. IT IS UNKNOWN IF PATIENT TREATMENT WAS IMPACTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97245 UNICEL® DXC 600 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1