BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172081 · Received June 15, 2011

    Report

    Report Number
    2122870-2011-01861
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    March 6, 2009
    Report Date
    March 7, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO INVESTIGATE THE EVENT. INITIALLY REAGENT PACK SHARING WAS SUSPECTED, THEREFORE, THE FSE COLLECT THE REAGENT INVENTORY RECORDS FROM BOTH INSTRUMENTS. AFTER FURTHER REVIEWING THE INVENTORY LOGS, IT WAS DETERMINED THAT A REAGENT PACK WAS SHARED BETWEEN BOTH INSTRUMENTS. THE CUSTOMER DID NOT REQUIRE HARDWARE VERIFICATION AFTER DETERMINING THAT THE ROOT CAUSE WAS REAGENT PACK SHARING. CUSTOMER ERROR IS THE ROOT CAUSE FOR THIS EVENT. THIS IS A SINGLE EVENT INVOLVING MULTIPLE PT SAMPLES. THERE WERE NO REPORTS OF ANY ADVERSE EVENT, CHANGES TO PT CARE OR ANY INDICATION THAT MEDICAL INTERVENTION WAS NEEDED TO PREVENT OR PRECLUDE ADVERSE EVENT. 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) 2009, IN REGARDS TO ELEVATED ACCUTNI RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR SEVERAL PATIENTS. THE CUSTOMER INDICATED THAT THEY WERE RECEIVING INDETERMINATE (IND) FLAGS FOR OTHER PATIENTS IN THE SAME EVENT. THE INITIAL ELEVATED RESULTS WERE REPORTED OUTSIDE THE LAB. THE PT SAMPLES WERE RETESTED ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE CORRECTED RESULTS WERE REPORTED OUT OF THE LAB. THERE ARE NOT REPORTS OF ANY ADVERSE PT CONSEQUENCE OR CHANGE TO THE PTS' TREATMENT. THERE ARE NO INDICATIONS OF ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT 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 ACCUTNI