BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 1963109 · Received January 18, 2011

    Report

    Report Number
    2122870-2011-00066
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 19, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS LITHIUM HEPARIN PLASMA, AND WAS CENTRIFUGED FOR 3 MINUTES. THE CENTRIFUGATION SPEED WAS NOT PROVIDED. QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO THE EVENT. THE SYSTEM CHECK WAS PERFORMED ON (B)(4) 2010 AND FAILED THE WASH PORTION. THE CUSTOMER REPEATED THE WASH PORTION OF THE SYSTEM CHECK AND THE RESULTS MET THE SPECIFICATIONS. SERVICE WAS ON SITE ON (B)(4) 2010. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED QC ON A NEW REAGENT PACK. THE RESULTS INDICATED THE ULTRASONICS WAS NOT PERFORMING AS EXPECTED. THE FSE REPLACED THE TRANSDUCER, THE ULTRASONICS BOARD, AND THE SERVICE LOOP CABLE. THE FSE PERFORMED A VERIFICATION TEST AND THE RESULTS WERE WITHIN THE SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO A TROPONIN (ACCUTNI) RESULT IN THE NORMAL REFERENCE RANGE GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED RESULTS WITHIN THE RISK STRATIFICATION RANGE. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1