BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2458509 · Received February 16, 2012

    Report

    Report Number
    2122870-2012-00393
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Date of Event
    January 16, 2012
    Report Date
    January 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    Z-0607-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THE CUSTOMER NOTED QUALITY CONTROL (QC) RECOVERY WAS WITHIN THE LABORATORY'S ACCEPTABLE RANGE ON (B)(6) 2012.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAILED ESTRADIOL QUALITY CONTROL (QC) RESULTS, GREATER THAN 4,909 PG/ML FOR ALL THREE LEVELS, INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. DURING TROUBLESHOOTING, THE CUSTOMER DISCOVERED THERE WAS NO ESTRADIOL REAGENT PACK IN COMPARTMENT 1 ON THE REAGENT CAROUSEL. BECKMAN COULTER, INC. CUSTOMER TECHNICAL SERVICE (CTS) ADVISED THE CUSTOMER TO LOCATE THE MIS-LOADED REAGENT PACK AND PROPERLY DISCARD IT. THE CUSTOMER CONFIRMED THERE WERE NO ERRORS IN THE EVENT INVENTORY REPORT AND DID NOT HAVE ISSUES WITH ANY OTHER ASSAYS. ALL OTHER REAGENTS MATCHED THE SOFTWARE INVENTORY. THE CUSTOMER STATED PATIENT RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. NO PATIENT SAMPLES WERE TESTED DURING THE REAGENT PACK MIS-LOAD DISCOVERY. CUSTOMER TECHNICAL SERVICE (CTS) ADVISED THE CUSTOMER TO RETEST ALL PATIENT SAMPLES DURING QUALITY CONTROL RECOVERY WAS WITHIN THE LABORATORY'S ACCEPTABLE RANGE, AND THE CUSTOMER ACKNOWLEDGED. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ESTRADIOL CALIBRATORS| ACCESS ESTRADIOL