BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1011828 · Received March 11, 2008

    Report

    Report Number
    2122870-2008-00079
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 24, 2008
    Report Date
    March 11, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC AND SYSTEM CHECK DATA WAS NOT PROVIDED. THE SAMPLE WAS A PLASMA TYPE. THE SPECIMEN WAS SAMPLED FROM A 0.5ML SAMPLE CUP IN THE APPROPRIATE SAMPLE CUP/RACK COMBINATION. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE PREFORMED A 50 POINT ACCU TNI PRECISION TESTING WITH GOOD RESULTS. THE FSE CONDUCTED A DIAGNOSTIC TESTING WHICH PARTIALLY FAILED WITH ONE OUTLIER. THE FSE REPLACED MIXER BELT AND BEARINGS. THE FSE RE-TENSIONED INCUBATOR BELT AND CALIBRATED IT WITH ACCEPTABLE RESULTS. THE FSE RERAN THE FAILED PORTION OF THE DIAGNOSTIC TESTING WHICH PASSED. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES WITH RESULTS MEETING PUBLISHED PERFORMANCE SPECS. IN A FOLLOW-UP IN 2008, THE FSE STATED THERE WERE NO INSTRUMENT ISSUES AND THE CUSTOMER HAS PRE-ANALYTICAL SAMPLE HANDLING ISSUES. THE FSE INDICATED THAT A SPECIALIST WILL BE SENT TO THE CUSTOMER'S LAB TO RETRAIN PERSONNEL ON PROPER SAMPLE COLLECTION. ALTHOUGH SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THIS EVENT, A CLEAR ROOT CAUSE FOR THIS EVENT 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 AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT THAT WAS GENERATED BY THE ACCESS 2 INSTRUMENT FOR A SINGLE PATIENT SAMPLE. THE INITIAL RESULT OF 4.86 NG/ML WAS REPORTED OUT OF THE LAB AND QUESTIONED BY A PHYSICIAN. THE ORIGINAL SAMPLE WAS RE-TESTED AND REPEATED RESULT WAS 0.02NG/ML. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT 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