BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1055430 · Received May 28, 2008

    Report

    Report Number
    2122870-2008-00160
    Event Type
    Other
    Date Received
    May 28, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 28, 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 AND CENTRIFUGATION WERE NOT SUPPLIED. THE CUSTOMER STATED THAT QC WAS WITHIN SPECIFICATION PRIOR TO THIS EVENT. SYSTEM CHECK INFO WAS NOT SUPPLIED. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE IN 2008: THE FSE REPLACED WASH WHEEL BEARINGS AND PERFORMED SYSTEM CHECK THAT FAILED SPECIFICATIONS. THE FSE REPLACED THE WASH VALVE ASSEMBLY AND PERFORMED A SYSTEM CHECK WHICH THEN PASSED WITHIN SPECIFICATION. THE FSE VERIFIED THE INSTRUMENT PER ESTABLISHED PROCEDURES. 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 ACCUTNI RESULTS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR SEVERAL PTS. CUSTOMER TESTED A SAMPLE FOR ACCUTNI AND OBTAINED A RESULT OF 10.75 NG/ML WHICH REPEATED AT 0.05 NG/ML. SAMPLES FROM 3 OTHER PTS GAVE RESULTS IN THE RANGE OF 0.39-7.10 NG/ML AND REPEAT RESULTS OF 0.02-0.07 NG/ML. SOME ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT ATTRIBUTED OR CONNECTED TO 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