BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1033184 · Received April 23, 2008

    Report

    Report Number
    2122870-2008-00128
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 23, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES FOR PT A WERE COLLECTED BY ER PERSONNEL FROM AN IV START AND COLLECTED INTO 13 X 75 LITHIUM HEPARIN PLASMA TUBES. THE SPECIMENS WERE CENTRIFUGED AT 3,500 RPM FOR 5 MINS. SAMPLING WAS PERFORMED DIRECTLY FROM THE PRIMARY TUBE. DETAILS REGARDING SAMPLE COLLECTION FOR PT B WERE NOT PROVIDED, BUT CUSTOMER INDICATED THEY RUN LITHIUM HEPARIN PLASMA FOR ALL PTS. IN 2008, THE CUSTOMER CONTACTED A CUSTOMER TECHNICAL SUPPORT (CTS) REGARDING QC ISSUE AND CALIBRATION FAILURE. AFTER TROUBLESHOOTING WITH CTS, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB THE NEXT DAY, AND PERFORMED FOLLOWING REPAIRS PRIOR TO THE EVENT. THE FSE REPLACED ASPIRATE PROBES, CLEANED WASH AND PRECISION VALVES. THE FSE PERFORMED ALIGNMENTS AND ADJUSTED ULTRASONIC'S. THE FSE CALIBRATED THE ISNTRUMENT AND CONDUCTED A MINI PRECISION TESTING AND SUGGESTED THE CUSTOMER RUN QC. QC WAS WITHIN SPECS SHOWING AN EXCELLENT PRECISION. A SYSTEM CHECK PERFORMED ON THE SAME DAY, PASSED. IT IS UNK IF THE TEST WAS DONE PRIOR OR AFTER THE FSE SERVICED THE INSTRUMENT. QC WAS PERFORMED THE FOLLOWING DAY, AND RESULTED WITHIN SPECS. ON THE SAME DAY, THE CUSTOMER STATED TO CTS THAT THEY DID NOT FEEL THAT THERE WAS AN ISSUE WITH THE INSTRUMENT. THE FSE WAS CALLED BACK AND THE INSTRUMENT'S PERFORMANCE WAS SATISFACTORY. A CLEAR ROOT CAUSE 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 TROPONIN (ACCU TNI) RESULTS GENERATED BY THE ACCESS 2 INSTRUMENT FOR TWO PTS. PT A: AN INITIAL SAMPLE FROM THIS PT WAS TESTED AT ANOTHER FACILITY FOR ACCU TNI AND A RESULT OF 0.01NG/ML WAS OBTAINED. THE RESULT WAS BELIEVED TO BE CORRECT AND WAS REPORTED OUT OF THE LAB. A 2ND SAMPLE FROM THE SAME COLLECTION TESTED ON THE ACCESS 2 INSTRUMENT GAVE A RESULT OF 5.48NG/ML. THE SAMPLE WAS RETESTED SEVERAL TIMES AND REPEATED RESULTS WERE IN THE RANGE OF 0.04-0.09NG/ML PT B: AN INITIAL ACCU TNI RESULT WAS 0.12NG/ML. THE SAMPLE WAS RETESTED SEVERAL TIMES AND RESULTS WERE: 0.89NG/ML, 0.09NG/ML, 0.02NG/ML, AND 0.03NG/ML. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. NO REPORT OF DEATH, INJURY, OR CHANGE TO PT TREATMENT HAS BEEN REPORTED TO BCI REGARDING THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA