BEUDAMED
    FDA Adverse Event Summary report: N

    ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1747371 · Received July 6, 2010

    Report

    Report Number
    2122870-2010-00294
    Date Received
    July 6, 2010
    Date of Event
    June 8, 2010
    Report Date
    July 6, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 06/07/2010 A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED UNIT REPAIRS. SERVICE WAS CANCELLED WHEN THE CUSTOMER DISCOVERED DURING TROUBLESHOOTING THAT THE REAGENT PACKS WERE NOT ONBOARD THE SYSTEM. THE ROOT CAUSE FOR THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO MULTIPLE QUALITY CONTROL RESULTS OF ZERO (0) AND/OR HAVING A CALCULATED CONCENTRATION ABOVE THE HIGHEST CALIBRATOR FOR INSULIN, CORTISOL, AND PARATHYROID HORMONE (PTH) RESULTS GENERATED BY THE ACCESS IMMUNOASSAY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1