BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2890435 · Received December 30, 2012

    Report

    Report Number
    2122870-2012-02033
    Event Type
    Malfunction
    Date Received
    December 30, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 30, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. A DEFINITIVE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED ERRATIC (IMPRECISE) TROPONIN I (ACCESS ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT, FOR ONE PATIENT, INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER STATED THE PATIENT HAD AN INITIAL RESULT, ABOVE THE AMI LIMIT, THAT WAS NOT QUESTIONED AS ERRONEOUS. THE PATIENT THEN UNDERWENT A CARDIAC CATHETERIZATION PROCEDURE AND SUBSEQUENT TROPONIN I RESULTS WERE ELEVATED ABOVE THE AMI LIMIT. A FINAL RESULT, ABOVE THE AMI LIMIT, WAS RELEASED OUTSIDE THE LABORATORY. THERE WAS NO EVIDENCE OF AN ERRONEOUS RESULT. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. THE EVENT WAS REPORTED AS PART OF BECKMAN COULTER MARKETING SURVEY PROGRAM (MSP) FOR TROPONIN. THE CUSTOMER DID NOT PROVIDE INFORMATION INDICATING AN INCREASE IN OCCURRENCE OR AN INSTRUMENT MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1