BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2000806 · Received February 24, 2011

    Report

    Report Number
    2122870-2011-00477
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND QC SYSTEM INFORMATION HAS NOT BEEN SUPPLIED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE PERFORMED A SUBSTRATE VOLUME CHECK WHICH FAILED. THE SUBSTRATE PUMP WAS ONLY DELIVERING 50% OF THE EXPECTED VOLUME. THE FSE REPLACED THE SUBSTRATE PUMP AND DECONTAMINATED THE SUBSTRATE SYSTEM. THE FSE RECALIBRATED ALL ASSAYS AND PERFORMED QC; NO ISSUES WERE NOTED. HARDWARE ISSUE, ADDRESSED BY THE FSE, IS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A LOWER THAN EXPECTED BHCG RESULT GENERATED BY THE ACCESS 2 INSTRUMENT FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LAB AND WAS QUESTIONED BY THE PHYSICIAN. SUBSEQUENT TESTING PRODUCED A HIGHER RESULT WITHIN A DIFFERENT GESTATIONAL CATEGORY. THE EFFECT, IF ANY, TO THE PATIENT IS UNKNOWN AT THIS TIME.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1