BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

    MDR report key: 2540121 · Received April 18, 2012

    Report

    Report Number
    2122870-2012-01063
    Event Type
    Malfunction
    Date Received
    April 18, 2012
    Date of Event
    March 20, 2012
    Report Date
    March 20, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CHP
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - TO CLARIFY THAT PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY USING THE NEW ANTIBODY.

    Description of Event or Problem · 1

    THE CUSTOMER SCREENED THE NEW REPLACEMENT ANTIBODY BEFORE REPORTING PATIENT RESULTS. THE SCREEN WAS CONDUCTED ON A 55 PATIENT COMPARATIVE STUDY BETWEEN ESTRADIOL2 LOT 117695 (NEW POLYCLONAL ANTIBODY REAGENT) AND LOT 110598. THE BIOCHEMIST REPORTED THE CORRELATION STUDIES SHOWED POSITIVE BIAS OF (B)(4) WHEN EVALUATING ACCESS ESTRADIOL REAGENT WITH NEW ANTIBODY REPLACEMENT, LOT 117695. PATIENTS RESULTS WERE REPORTED OUT OF THE LABORATORY USING THE NEW ANTIBODY. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT. THE CUSTOMER STATED THIS POSITIVE BIAS IS LARGE AND MAY IMPACT INTERPRETATION IN POST MENOPAUSAL FEMALES AND MALES. THE CUSTOMER WILL SEND PATIENT SAMPLES FOR ESTRADIOL TO ALTERNATE FACILITY TO BE TESTED UNDER ALTERNATE METHODOLOGY. CONTROLS WERE RUN BEFORE AND AFTER EVENT. THE UNIT CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PREVISION). SERVICE WAS NOT DISPATCHED FOR THIS EVENT. ROOT CAUSE IN UNKNOWN. INSTRUMENT ASSOCIATED WITH THIS EVENT IS DEVICE NAME: UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. CLASSIFICATION CODE: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE. CATALOG NUMBER: A30260; SERIAL NUMBER: (B)(4); SOFTWARE VERSION: 4.4; MANUFACTURE DATE: 05/07/2009.

    Description of Event or Problem · 1

    PATIENTS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY USING THE NEW ANTIBODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER RADIOIMMUNOASSAY, ESTRADIOL CHP BECKMAN COULTER INC. ESTRADIOL REAGENT PACKS 117695

    Patients

    Seq Age Sex Outcome Treatment
    1