BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2142174 · Received May 26, 2011

    Report

    Report Number
    2122870-2011-01487
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    December 27, 2008
    Report Date
    December 30, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE QUALITY CONTROL (QC) DATA FOR (B)(6) 2008 PROVIDED BY THE CUSTOMER WAS REVIEWED. THIS REVIEW DID NOT INDICATE ANY ABNORMALITIES AND ALL INFORMATION WAS WITHIN SPECIFICATION. THE SYSTEM CHECKS DATA THAT WAS PERFORMED ON (B)(6) 2008 WAS REVIEWED AND IT WAS WITHIN INSTRUMENT SPECIFICATIONS. FOLLOWING THIS EVENT, BCI SENT A NEW REAGENT LOT TO THE CUSTOMER TO CONDUCT CORRELATION STUDIES AT THE USER SITE. PATIENT CORRELATION STUDIES WERE PERFORMED BY THE CUSTOMER AND THE RESULTS WERE WITHIN EXPECTED RANGE FOR ALL PRODUCTS. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED FOR THIS EVENT. THIS IS THREE OF ELEVEN SEPARATE MDR REPORTS RELATED TO ELEVEN PATIENT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS 2122870-2011-01485, 2122870-2011-01486. 2122870-2011-01488, 2122870-2011-01489, 2122870-2011-01490, 2122870-2011-01491, 2122870-2011-01492, 2122870-2011-01493, 2122870-2011-01494, 2122870-2011-01495 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) ON (B)(6) 2008 IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ELEVEN PATIENTS. THE PATIENT SAMPLES WERE RETESTED AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. 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. THIS REPORT REFERS TO PATIENT NUMBER THREE.

    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 UNK ACCESS ACCUTNI