BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2I IMMUNOASSAY ANALYZER

    MDR report key: 2082425 · Received May 10, 2011

    Report

    Report Number
    2122870-2011-01337
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 9, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION DATA WERE NOT SUPPLIED. WHILE TROUBLESHOOTING WITH BCI CUSTOMER TECHNICAL SPECIALIST (CTS), CUSTOMER NOTED THAT THE WHITE FITTINGS WERE LOOSE, WHICH CUSTOMER PROCEEDED TO TIGHTEN. CUSTOMER THEN RAN A SYSTEM CHECK WHICH PASSED. CTS FOLLOWED UP WITH CUSTOMER AND CUSTOMER STATED THERE WERE NO FURTHER ISSUES. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT GETTING INDETERMINATE (IND) FLAGS GENERATED BY THE ACCESS 2I IMMUNOASSAY ANALYZER ON FOUR (4) DIFFERENT PATIENT VALUES FOR TROPONIN (ACCUTNI). THE RESULTS WERE NOT REPORTED OUT OF THE LAB AND THERE WAS NO EFFECT ON PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2I IMMUNOASSAY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. ACCESS® 2I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1