BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 1943217 · Received December 30, 2010

    Report

    Report Number
    2122870-2010-00993
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE CENTRIFUGED AT 3000RPM FOR 6 MINUTES. QC IS PERFORMED EVERY 8 HOURS AND WAS WITHIN THE ESTABLISHED RANGES. A BCI FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(6) 2010. THE INITIAL DIAGNOSTIC SYSTEM CHECK FAILED. THE FSE REPLACED MIXER BELT AND PERFORMED ALIGNMENTS. A REPEAT SYSTEM CHECK MET THE SPECIFICATIONS. A HIGH SENSITIVITY SYSTEM CHECK FAILED. ADJUSTMENTS WERE MADE TO THE WASH ARM ALIGNMENTS AND THE DISPENSE VOLUME WAS CHECKED. A REPEAT HIGH SENSITIVITY SYSTEM CHECK MET THE SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS IN THE RISK STRATIFICATION RANGE AND ABOVE THE AMI CUTOFF GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE ERRONEOUSLY ELEVATED ACCUTNI RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other