BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2243961 · Received August 19, 2011

    Report

    Report Number
    2122870-2011-02970
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    September 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DECLINED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THE CUSTOMER SUSPECTED SAMPLE HANDLING AS THE LIKELY CAUSE OF THE EVENT. QUALITY CONTROL WAS WITHIN SPECIFICATIONS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ELEVATED CREATINE KINASE-MB (CK-MB) RESULT, ABOVE THE NORMAL REFERENCE RANGE, FOR ONE PT INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER RETESTED THE SAMPLE AND PRODUCED LOWER CK-MB RESULTS. THE ELEVATED RESULT WAS RELEASED OUT OF THE LAB. THERE HAS BEEN NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS CK-MB