BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1065945 · Received June 25, 2008

    Report

    Report Number
    2122870-2008-00204
    Event Type
    Other
    Date Received
    June 25, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND HANDLING DETAILS WERE NOT SUPPLIED. CUSTOMER TECHNICAL SUPPORT (CTS) HAD BEEN WORKING WITH CUSTOMER ON A QC ISSUE AND DISCOVERED THE CALIBRATOR BEING ELEVATED ABOVE ITS EXPECTED VALUE. PER CTS, THE CUSTOMER RAN A SYSTEM CHECK WHICH PASSED. QC WAS PERFORMED AND ACCU TNI LEVEL 1 WAS OUT OF RANGE. THE SAME CALIBRATOR VIAL PRODUCED SIMILAR ELEVATED RESULTS ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND A NEW CALIBRATOR WAS SENT TO THE CUSTOMER. PER CUSTOMER, ANY SUSPECT CALIBRATOR HAS BEEN DISCARDED AND THUS UNAVAILABLE FOR FURTHER INVESTIGATION. SERVICE WAS NOT DISPATCHED REGARDING THIS EVENT AS CTS TROUBLESHOOTING DETERMINED THE EVENT IS NOT LIKELY INSTRUMENT RELATED. IN A F/U WITH CUSTOMER, BCI REP SUGGESTED REFRAINING FROM REPORTING RESULTS IF ISSUES ARE UNRESOLVED AND TO CONTACT BCI FOR ASSISTANCE OR SERVICE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY ELEVATED ACCU TNI RESULTS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR SEVERAL ER PTS. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LAB; HOWEVER, DETAILS HAVE NOT BEEN SUPPLIED BY THE CUSTOMER TO DATE. TO DATE, THE CUSTOMER HAS NOT REPORTED ANY DEATH, INJURY, OR CHANGE TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA