BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172085 · Received June 15, 2011

    Report

    Report Number
    2122870-2011-01777
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    February 3, 2009
    Report Date
    February 4, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELLED THE SERVICE CALL. THE FIELD SERVICE ENGINEER (FSE) DID NOT EVALUATE THE DEVICE. QUALITY CONTROL (QC) DATA WAS REVIEWED AND IT WAS RECOVERING WITHIN +/- 2 STANDARD DEVIATION (SD) PRIOR TO AND ON THE DATE OF THE EVENT. NO DEFINITIVE CAUSE COULD BE DETERMINED FOR THIS EVENT. THIS IS ONE OF THREE SEPARATE MDR REPORTS RELATED TO THREE PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REF MDR#S: 2122870-2011-01777, 01778, 01883 FOR ALL EVENT. THIS 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 THREE PTS. THE PT SAMPLES WERE RETESTED AND THE RESULTS RECOVERED WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LAB. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PT 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 JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR ACCESS ACCUTNI