BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2232023 · Received September 1, 2011

    Report

    Report Number
    2122870-2011-03180
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN TUBES. CENTRIFUGATION DATA WAS NOT SUPPLIED. NO SPECIFIC EVENT QC DATA WAS SUPPLIED. THE INSTRUMENT WAS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS UPON CONTACT WITH THE CUSTOMER. THE LABORATORY DOES NOT HAVE AN ACTIVE ACCUTNI PATIENT SAMPLE REPEAT ANALYSIS PROCEDURE. THE CUSTOMER NOTED THAT THERE HAD BEEN NO OTHER INSTANCES. THE LABORATORIES CUT-OFF FOR POSITIVE TROPONIN RESULTS IS 0.06NG/ML, BUT WILL SOON BE CHANGING IT TO 0.5NG/ML AT THE REQUEST OF THE MEDICAL STAFF. THE CUSTOMER DID NOT PROVIDE INFORMATION INDICATING AN INCREASE IN OCCURRENCE OR AN INSTRUMENT MALFUNCTION. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER WAS CONTACTED BY BECKMAN COULTER, INC. (BEC) REGARDING ACCUTNI ASSAY PERFORMANCE AND INDICATED AN OCCURRENCE OF NON-REPRODUCIBLE FALSE POSITIVE TROPONIN (ACCUTNI) RESULT GENERATED BY UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT'S SAMPLE. THE RESULT WAS REPORTED OUT OF THE LABORATORY, AND QUESTIONED BY THE PHYSICIAN BECAUSE, THE RESULT DID NOT FIT WITH THE PATIENT'S CLINICAL HISTORY AND CONCURRENT CKMB RESULTS. REPEAT TESTING PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE PATIENT REPORT WAS AMENDED. THE CUSTOMER DID NOT PROVIDE INFORMATION REGARDING REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM DISCRETE PHOTOMETRIC CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1