BEUDAMED
    FDA Adverse Event Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1884304 · Received October 27, 2010

    Report

    Report Number
    2122870-2010-00639
    Date Received
    October 27, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TROUBLESHOOTING THE EVENT WITH ACCESS HOTLINE, THE CUSTOMER DISCOVERED THAT THE UNLOADED REAGENT PACK WAS EMPTY AND THRITY FOUR (34) TESTS WERE REMAINING. SERVICE WAS NOT DISPATCHED. ALTHOUGH REAGENT PACK SHARING IS SUSPECTED AS A CONTRIBUTING FACTOR, A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BC) IN REGARDS TO MULTIPLE INDETERMINATE RESULTS (IND) AND NO VALUES ON UNKNOWN NUMBER OF PATIENTS' SAMPLES GENERATED BY ACCESS2 IMMUMOANALYZER; HOWEVER, THE RESULTS ARE NOT PROVIDED. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE IN TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1