BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1970786 · Received January 25, 2011

    Report

    Report Number
    2122870-2011-00092
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 27, 2010
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED INFORMATION THAT A PROACTIVE PROCEDURE HAS BEEN IMPLEMENTED TO VERIFY UNEXPECTED RESULTS PRIOR TO REPORTING RESULTS OUT OF THE LABORATORY THEREBY PREVENTING POTENTIAL RISK TO PATIENT SAFETY. ALL PATIENT SAMPLES WITH UNEXPECTED RESULTS ARE TO BE RE-SPUN AND RE-ANALYZED. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER WAS CONTACTED BY BECKMAN COULTER, INC. (BCI) VIA ACCUTNI COSTUMER CONTACT PROGRAM AND REPORTED SOME OCCURRENCES OF NON-REPRODUCIBLE FALSE POSITIVE TROPONIN (ACCUTNI) RESULTS GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT REPORT EFFECT TO PATIENT OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1