BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2242277 · Received September 10, 2011

    Report

    Report Number
    2122870-2011-03586
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 26, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. PER BECKMAN COULTER ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT PERFORMANCE DATA, AN INSTRUMENT SYSTEM CHECK PERFORMED PRIOR TO THE EVENT GENERATED ACCEPTABLE RESULTS. ALSO, ALL PORTIONS OF CARRYOVER TESTING WERE WITHIN PUBLISHED SPECIFICATIONS BECKMAN COULTER INC. CUSTOMER PRODUCT LINE SUPPORT IS CURRENTLY INVESTIGATING THIS EVENT. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-03586; 2122870-2011-03587.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT LEVEL ONE HUMAN CHORIONIC GONADOTROPIN (BHCG) QUALITY CONTROL (QC) RESULTS, FAILING TO MEET ESTABLISHED SPECIFICATION, WERE GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM ON TWO DAYS. THIS REPORT IS ONE OF TWO AND REPRESENTS THE FAILING, ELEVATED BHCG QC RESULTS, OUTSIDE THE CUSTOMER'S UPPER SPECIFICATION LIMITS, GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM ON (B)(6) 2011. NO ERRONEOUS PATIENT RESULTS WERE RELEASED FROM THE LABORATORY IN CONNECTION TO THE EVENT. THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. UPON RECALIBRATION USING A NEW REAGENT PACK, THE CUSTOMER WAS ABLE TO GENERATE QUALITY CONTROL RESULTS WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS. NO SAMPLE HANDLING/COLLECTION INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS TOTAL SSHCG REAGENT