BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2I (LXI) IMMUNOASSAY SYSTEM

    MDR report key: 1972121 · Received January 27, 2011

    Report

    Report Number
    2122870-2011-00154
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 26, 2010
    Report Date
    December 30, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN A LI HEPARIN PST THAT WAS CENTRIFUGED FOR 3 MINUTES AT 4000RCF. PER THE CUSTOMER, THE COLLECTION TUBE WAS FULL AND APPEARED NORMAL. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE ERRONEOUS RESULTS. A SYSTEM CHECK WAS PERFORMED ON (B)(4) 2010 AND MET SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2010 AND PERFORMED HARDWARE SERVICE ON THE ASSAYS, WHICH MET SPECIFICATIONS. THE FSE REPLACED THE PIPETTOR TIP, THE WASH TOWER NOZZLE, AND THE PRECISION PUMP SEALS AS A PRECAUTION. NO HARDWARE ISSUES WERE NOTED. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN ERRONEOUSLY ELEVATED RESULT FOR ACCUTNI (TROPONIN) WITHIN THE RISK STRATIFICATION RANGE FOR ONE PATIENT'S SAMPLE GENERATED BY THE ACCESS 2I (LXI) IMMUNOASSAY SYSTEM. UPON REPEAT THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE, WHICH WAS REPORTED OUT OF THE LABORATORY. 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® 2I (LXI) IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. ACCESS® 2I (LXI) NA

    Patients

    Seq Age Sex Outcome Treatment
    1