BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2230311 · Received September 1, 2011

    Report

    Report Number
    2122870-2011-03358
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS INCIDENT. THE FIELD SERVICE ENGINEER VERIFIED THAT ALL ALIGNMENTS WERE ON TARGET. NO ADJUSTMENTS WERE MADE. THE REAGENT CAROUSEL LID WAS REPLACED AND RETURNED TO BECKMAN COULTER INC. CUSTOMER PRODUCT LINE SUPPORT FOR ADDITIONAL EVALUATION. EVALUATION IS CURRENTLY ON-GOING. THE FSE PRIMED THE SYSTEM AND PERFORMED ASSAY QUALITY CONTROL, WHICH WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THIS EVENT TO DATE. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-02282, 2122870-2011-02912, 2122870-2011-03358, 2122870-2011-02231.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING HUMAN CHORIONIC GONADOTROPIN (BHCG) LEVEL 1 QUALITY CONTROL (QC) RESULTS WHICH WERE OUTSIDE THE CUSTOMER ESTABLISHED SPECIFICATION LIMITS ON AN ACCESS 2 IMMUNOASSAY ANALYZER WHEN THERE WERE APPROXIMATELY FIFTEEN TESTS REMAINING IN THE BHCG REAGENT PACK. THE CUSTOMER REPLACED THE IN-USE REAGENT PACK WITH A NEW REAGENT PACK. THE INSTRUMENT BHCG QC WAS REPEATED AND ALL LEVELS RECOVERED WITHIN THE CUSTOMER'S ESTABLISHED RANGES. PATIENT SAMPLE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE SAME ISSUE HAD OCCURRED PREVIOUSLY FOR THIS CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS TOTAL SSHCG REAGENT