BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 781250 · Received November 7, 2006

    Report

    Report Number
    2122870-2006-00234
    Event Type
    Other
    Date Received
    November 7, 2006
    Date of Event
    October 12, 2006
    Report Date
    November 7, 2006
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN CUSTOMER'S SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. SYSTEM CHECKS PERFORMED ON 10/06/06 AND 10/13/06 PASSED. CUSTOMER COLLECTS SAMPLES IN BD, 13X100, PLASTIC, LITHIUM HEPARIN TUBES WITH GEL SEPARATORS AND CENTRIFUGES AT 4,500 RPM FOR 5 MINUTES AT AMBIENT TEMPERATURE. THE CUSTOMER STATED THAT BOTH SAMPLES WERE DRAWN BY RN FROM A LINE AND WERE VISUALLY FREE OF FIBRIN AND HEMOLYSIS. SAMPLE A WAS A SHORT DRAW. NO FLAGS WERE ASSOCIATED WITH THIS SAMPLE RESULT. THE SPECIMENS WERE SAMPLED FROM PRIMARY TUBES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB ON 10/16/2006. THE FSE PERFORMED A MAJOR PREVENTIVE MAINTENANCE (PM) TO THE INSTRUMENT. THE FSE NOTED A DRIED WASH BUFFER ON MIXER PULLEY 0-RINGS. THE FSE REPLACED WASH PUMP AND MAIN PIPETTOR PROBE. THE FSE CONDUCTED DIAGNOSTIC TESTING; RESULTS PASSED WITHIN SPECIFICATIONS,.THE FSE VERIFIED THE INSTRUMENT WAS OPERATING PER ESTABLISHED PROCEDURES. THE FSE DISCUSSED SAMPLE HANDLING WITH THE CUSTOMER. ALTHOUGH HARDWARE ISSUES ADDRESSED BY THE FSE MAY HAVE CONTRIBUTED TO THIS EVENT, 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 AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNL) RESULT FROM A SINGLE PT SAMPLE THAT WAS GENERATED BY THE ACCESS 2 INSTRUMENT. AN ER PT SAMPLE (A) WAS TESTED FOR ACCU TNL AND A RESULT OF 0.51 NG/ML WAS OBTAINED. THE ACCU TNL RESULT WAS REPORTED OUT OF THE LAB. A NEW SAMPLE (B) WAS COLLECTED FROM THE PT APPROX 4 HOURS LATER AND TESTED FOR ACCU TNL; THE RESULT WAS 0.02 NG/ML. THE CUSTOMER THEN RE-TESTED BOTH SAMPLES FOR ACCU TNL AND OBTAINED 2 RESULTS OF 0.01 NG/ML. THE PT WAS TREATED WITH HEPARIN, ASPIRIN AND NITROGLYCERIN DUE TO THE ERRONEOUS RESULT REPORTED. HOWEVER, THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION THAT CAN BE ATTRIBUTED TO 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