BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS2 IMMUNOASSAY SYSTEM

    MDR report key: 858088 · Received May 30, 2007

    Report

    Report Number
    2122870-2007-00120
    Event Type
    Other
    Date Received
    May 30, 2007
    Date of Event
    May 6, 2007
    Report Date
    May 30, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL QC DATA WAS NOT PROVIDED. HOWEVER, CUSTOMER REPORTED ALL THREE LEVELS OF ACCU TNI QC WERE OUT OF SPECIFICATIONS HIGH AFTER THE ERRONEOUS RESULT WAS OBTAINED. THE CUSTOMER WAS ADVISED TO PERFORM A SYSTEM CHECK. THE CUSTOMER COLLECTS SAMPLES IN 13X100, BD, LITHIUM HEPARIN TUBES AND THEY STATED THAT THE TUBE WAS HALF FULL. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB IN 2007: THE FSE INDICATED THAT THE SYSTEM CHECK PERFORMED BY THE CUSTOMER RESULTED WITH HIGH % CVS. THE FSE INSPECTED THE INSTRUMENT AND FOUND PINCHED WASH BUFFER INPUT TUBING WHICH WAS CORRECTED. THE FSE PRIMED LINES AND PERFORMED SYSTEM CHECK WHICH PASSED WITHIN SPECIFICATIONS. THE FSE VERIFIED THE INSTRUMENT PER ESTABLISHED PROCEDURES. HARDWARE ISSUES ADDRESSED BY THE FSE MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED IN THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT FROM A SINGLE PATIENT SAMPLE THAT WAS GENERATED BY THE ACCESS2 INSTRUMENT. BASED ON AVAILABLE INFORMATION, THE CUSTOMER OBTAINED AN ACCU TNI RESULT ABOVE THE AMI CUT-OFF. THE HIGH RESULT DID NOT CORRELATE WITH OTHER CARDIAC MARKERS OR CLINICAL PRESENTATION OF THE PATIENT. THE CUSTOMER INDICATED THAT THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LAB AND QUESTIONED BY A PHYSICIAN. THE SAMPLE WAS RE-TESTED AND THE REPEATED ACCU TNI RESULT WAS WITHIN NORMAL RANGE. THE ACTUAL PATIENT RESULTS WERE NOT SUPPLIED BY THE CUSTOMER. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. ACCESS 2 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR