BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2142178 · Received May 26, 2011

    Report

    Report Number
    2122870-2011-01494
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    December 28, 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. PT 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 TEN OF ELEVEN SEPARATE MDR REPORTS RELATED TO ELEVEN PTS EVENT ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCES MDR NUMBERS: 2122870-2011-01485, 01486, 01487, 01488, 01489, 01490, 01491, 01492, 01493, 01495 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 TO (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BCI) ON (B)(6) 2008, IN REGARDS TO ERRONEOUSLY ELEVATED ACCU-TNI RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ELEVEN PTS. THE PT 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 PT TREATMENT. THERE IS NO INDICATION OF AN ADVERSE EVENT OR INDICATION OF ANY MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY. THIS REPORT REFERS TO PT NUMBER TEN.

    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