BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1061497 · Received June 17, 2008

    Report

    Report Number
    2122870-2008-00186
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 26, 2008
    Report Date
    June 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS PERFORMED AFTER THE ERRONEOUS RESULT WAS OBTAINED AND LEVEL I WAS BARELY IN THE CUSTOMER'S RANGE, AND LEVEL III WAS OUT OF SPECIFICATIONS. THE LEVEL III PASSED UPON REPEAT. A SYSTEM CHECK PERFORMED IN 2008 FAILED PARTIALLY, AND PASSED UPON REPEAT. NO ERRORS WERE POSTED TO THE EVENT LOG. THE SPECIMENS WERE COLLECTED IN BD, LITHIUM HEPARIN PST TUBES AND CENTRIFUGED AT 5,100 RPM FOR 5 MINUTES. PER CUSTOMER THE SAMPLES APPEARED NORMAL. BD RECOMMENDS A SPIN TIME OF 10 MINUTES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE PERFORMED A MAJOR PREVENTIVE MAINTENANCE (PM) WHICH WAS OVERDUE: THE FSE REPLACED A TRANSDUCER. THE FSE FOUND AN UNUSUAL SPLATTER IN THE WASH WHEEL AND PERI TUBING THAT WAS SIGNIFICANTLY FLATTENED MOST LIKELY DUE TO AGE. PER FSE, THE FLATTENED TUBING MAY HAVE CONTRIBUTED TO THE SPLATTER IN THE WASH CAROUSEL. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. 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 AN ERRONEOUS TROPONIN (ACCU TNI) RESULT GENERATED BY THE ACCESS 2 INSTRUMENT FOR ONE PATIENT. A PATIENT SAMPLE WAS TESTED FOR ACCU TNI AND A RESULT OF 0.05NG/ML WAS REPORTED OUT OF THE LAB. A FRESH SAMPLE COLLECTED ON THE NEXT DAY GAVE A RESULT OF 3.23NG/ML AND WAS REPORTED OUT OF THE LAB AND QUESTIONED BY A PHYSICIAN. THE SAMPLE WAS RE-TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND REPEATED RESULT WAS 0.04NG/ML. A CORRECTED REPORT WAS SUBMITTED. A 3RD SAMPLE TESTED ON THE ACCESS 2 INSTRUMENT GAVE A RESULT OF 0.03NG/ML AND WAS REPORTED. NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT OCCURRED IN ASSOCIATION TO 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. ACCESS2 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA