BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2142166 · Received May 26, 2011

    Report

    Report Number
    2122870-2011-01437
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    December 14, 2008
    Report Date
    December 14, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BCI OFFERED TO EVALUATE/SERVICE THE INSTRUMENT, HOWEVER, THE CUSTOMER DECLINED THIS OFFER. ACCORDINGLY, NO SYSTEM EVALUATION COULD BE PERFORMED. NO CONCLUSION CAN BE DRAWN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) ON (B)(6) 2008 REGARDING ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN) RESULT GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE CUSTOMER RE-RAN THE SAMPLE ON A DIFFERENT INSTRUMENT AND THEY WERE WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL ELEVATED ACCUTNI RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER ALSO INDICATED THAT THE LAST SYSTEM CHECK WAS PERFORMED ON (B)(6) 2008 AND THE RESULTS WERE WITHIN SPECIFICATION. CUSTOMER REVIEWED THE EVENT LOG AND FOUND NO SIGNIFICANT ERRORS AROUND THE TIME OF THE EVENT. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PATIENT TREATMENT. THERE IS NO INDICATION OF AN ADVERSE EVENT OR INDICATION OF ANY MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR ACCESS ACCUTNI