BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1721287 · Received June 11, 2010

    Report

    Report Number
    2122870-2010-00250
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    May 7, 2010
    Report Date
    June 11, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    KXT
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE IS LI HEPARIN PLASMA COLLECTED IN A PST TUBE.QC WAS WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE EVENT.A SYSTEM CHECK PERFORMED ON (B)(6)2010 MET SPECIFICATIONS.A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE (B)(6)2010. FSE "FINELY TUNED" THE ULTRASONICS AND PERFORMED A SYSTEM CHECK WHICH MET SPECIFICATIONS. NO HARDWARE ISSUES WERE NOTED.ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A FALSELY ELEVATED DIGOXIN RESULT GENERATED BY THE ACCESS® 2 IMMUNOASSAY SYSTEM ON ONE PATIENT.THE RESULTS ARE SHOWN. UPON REPEAT TESTING THE RESULTS WERE WITHIN THE THERAPEUTIC RANGE.NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER KXT BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1