BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2222160 · Received August 24, 2011

    Report

    Report Number
    2122870-2011-02955
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN REAGENT PACK SHARING OCCURS, THE INSTRUMENT DOES NOT DETECT THAT THE PACK TEST COUNT IS INCORRECT. AFTER TROUBLESHOOTING, BEC CUSTOMER TECHNICAL SUPPORT REQUESTED THE CUSTOMER TO CALL BACK IF ANY ISSUES WERE NOTED. USE ERROR IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING 0 NG/ML FOR ALL LEVELS OF TROPONIN (ACCUTNI) QC ON AN ACCESS 2 IMMUNOASSAY ANALYZER. WHILE TROUBLESHOOTING WITH BEC ACCESS HOTLINE, AN ACCUTNI REAGENT PACK WAS FOUND TO HAVE BEEN SHARED BETWEEN THE CUSTOMER'S TWO ACCESS 2 IMMUNOASSAY ANALYZERS. THE CUSTOMER STATED THAT NO PATIENT RESULTS WERE AFFECTED. BECAUSE ACCUTNI QC WAS OUT OF THE CUSTOMER'S RANGES, ALL ACCUTNI PATIENT SAMPLES TESTED DURING THE EVENT WERE RETESTED AND RESULTS WERE REPRODUCIBLE. EXACT NUMBER OF PATIENTS AND TEST RESULTS WERE NOT SUPPLIED BY THE CUSTOMER. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE MMI BECKMAN COULTER, INC. ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1