BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS

    MDR report key: 2121871 · Received May 20, 2011

    Report

    Report Number
    2122870-2011-01316
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    May 10, 2010
    Report Date
    May 11, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL (QC) ANALYSIS SHOWS THE FIELDED LOT MET ALL RELEASE SPECIFICATIONS AND ALL KEY LABEL/PERFORMANCE CLAIMS. A SYSTEM CHECK DATA WAS PROVIDED BY THE CUSTOMER, AND ALL SYSTEM PARAMETERS WERE WITHIN SPECIFICATION. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 TO OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED PATIENTS' RESULTS FOR TROPONIN WERE HIGH COMPARED WITH A PREVIOUS TROPONIN (ACCUTNI) REAGENT LOT. THE CUSTOMER PERFORMED TWO CALIBRATIONS ON THE SAME DAY WITH THE SUSPECT REAGENT. THE CUSTOMER STATED PATIENTS' SAMPLES WERE TESTED WITHIN ONE HOUR OF EACH OTHER FOR COMPARISON. THE CUSTOMER HAS AN ACCEPTABILITY FACTOR OF 1.0 STANDARD DEVIATION (SD) OR LESS AND WAS RECEIVING 2.9 SD AND 3.1 SD ON BOTH TESTS. THE HIGHER PATIENTS' RESULTS DID NOT MEET THE CUSTOMER'S REQUIRED ACCEPTABILITY FACTOR AND WERE NOT ACCEPTED FOR REPORTING. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MMI BECKMAN COULTER, INC. NA 010030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS 2 IMMUNOASSAY SYSTEM