BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX DELTA SYSTEMS

    MDR report key: 2362313 · Received December 7, 2011

    Report

    Report Number
    2050012-2011-08335
    Event Type
    Malfunction
    Date Received
    December 7, 2011
    Date of Event
    November 2, 2011
    Report Date
    November 7, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER. ON-SITE SERVICE WAS NOT REQUESTED. A REPLACEMENT REAGENT WAS SENT TO THE CUSTOMER. SERVICE NOT REQUESTED BY CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6) 2011, CUSTOMER REPORTED ERRATIC LIPASE RESULTS GENERATED ON THE CX9 INSTRUMENT FOR (B)(6) 2011. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO IMPACT TO PATIENT TREATMENT BASED ON THE ERRONEOUS RESULTS. PER THE CUSTOMER'S DATA, THE CONTROLS AND PATIENT RESULT VALUES DO NOT MATCH WITH BECKMAN COULTER'S (BEC) REFERENCE RANGE OR THE ANALYTICAL RANGE. MULTIPLE ATTEMPTS TO REQUEST FOR CLARIFICATION HAVE BEEN UNSUCCESSFUL. ON (B)(6) 2011, CUSTOMER CONTACT CONFIRMED THAT THE CUSTOMER RAN THIS AS A UDR (USER DEFINED REAGENT). THE TECHNICIAN WHO ORIGINALLY REPORTED THIS PROBLEM WAS NOT AVAILABLE TO PROVIDE ADDITIONAL INFORMATION. IT IS UNKNOWN WHICH RESULT IS THE CORRECT RESULT. PER CUSTOMER ADVOCATE, THE CUSTOMER NOW REPORTS THAT ALL IS WORKING 100%. THE ROOT CAUSE IS UNKNOWN. ON-SITE SERVICE WAS NOT REQUESTED. A REPLACEMENT REAGENT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX DELTA SYSTEMS ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. CX9 ALX

    Patients

    Seq Age Sex Outcome Treatment
    1