BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 864259 · Received May 3, 2007

    Report

    Report Number
    2122870-2007-00097
    Event Type
    Other
    Date Received
    May 3, 2007
    Date of Event
    April 10, 2007
    Report Date
    May 3, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS PRIOR TO THE EVENT. FOLLOWING THE ELEVATED RESULTS, THE CUSTOMER REPEATED QC AND RESULTS WERE OUT OF SPECIFICATIONS HIGH. SYSTEM CHECK PERFORMED IN 2007 PASSED. THE SPECIMEN WAS COLLECTED IN 13 X 75, LITHIUM HEPARIN TUBE WITH GEL AND CENTRIFUGED AT 3,800 RPM FOR 6 MINUTES. PRECISION VALVE/PUMP MOTION AND WASH VALVE/PUMP MOTION ERRORS WERE OBTAINED AT THE TIME OF THIS EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB FIVE DAYS LATER: THE FSE INSPECTED THE INSTRUMENT AND DISCOVERED A LEAK IN PRESSURE IN THE VACUUM PUMP. THE FSE REPLACED THE VACUUM PUMP. THE FSE CONDUCTED DIAGNOSTIC TESTING WHICH PASSED WITHIN SPECIFICATIONS. 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 ERRORNEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULTS FROM A SINGLE PT SAMPLE THAT WERE GENERATED BY THE ACCESS 2 INSTRUMENT. A PT SAMPLE WAS TESTED FOR ACCU TNI SEVERAL TIMES AND RESULTS WERE: FIRST 2 RESULTS WERE "NO VALUE SYS ERROR". A 3RD RESULT OF 4.72 NG/ML WAS REPORTED OUT OF THE LAB. A 4TH RESULT WAS ">100.00NGML". THE CUSTOMER INDICATED THAT THE ORIGINAL SAMPLE WAS TESTED FOR ACCU TNI ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND A RESULT OF 0.01 NG/ML WAS OBTAINED. PER CUSTOMER, PT WAS SENT TO CRITICAL CARE FOR OBSERVATION ONLY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY OR DEATH ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA