BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172091 · Received June 15, 2011

    Report

    Report Number
    2122870-2011-01857
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    February 10, 2009
    Report Date
    February 10, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON SITE ON (B)(4) 2009 TO INVESTIGATE THE EVENT. THE FSE NOTED THAT THE CUSTOMER RAN A CARRYOVER TEST WHICH PRODUCED FAILING RESULTS. THE FSE CHANGED THE ASPIRATE PROBE TUBING, SUBSTRATE PROBE, MAIN PIPETTOR TIP, AND VESSEL HOLDERS. ALSO, THE FSE VERIFIED ALIGNMENTS, PRIMED THE INSTRUMENT, AND RAN A SYSTEM CHECK WHICH FAILED THE UNWASHED PORTION. THE FSE CHANGED THE WASH TOWER INSERT, VERIFIED ALIGNMENTS, VERIFIED VACUUM, AND REPEATED THE UNWASHED PORTION OF THE SYSTEM CHECK WHICH PASSED. THE FSE PERFORMED THE CARRYOVER TEST WHICH PASSED AND RAN QUALITY CONTROLS (QC) WHICH YIELDED PASSING RESULTS WITHIN THE CUSTOMER'S RANGES. THE FSE VERIFIED THE REPAIRS PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) ON (B)(6) 2009 IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PT. THE PT SAMPLE WAS RETESTED AND THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WAS NOT REPORTED OUTSIDE THE LAB. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCE OR CHANGE TO THE PT'S 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 59 YR ACCESS ACCUTNI