BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1751503 · Received July 10, 2010

    Report

    Report Number
    2122870-2010-00305
    Event Type
    Malfunction
    Date Received
    July 10, 2010
    Date of Event
    June 12, 2010
    Report Date
    July 9, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE LITHIUM HEPARIN THAT WERE CENTRIFUGED AT 3,000 PM FOR 5 MINUTES. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK PERFORMED ON (B)(4) 2010 MET SPECIFICATIONS. THE CUSTOMER'S OWN BIO-MED DEPARTMENT IS CURRENTLY WORKING WITH BCI TECHNICAL SUPPORT. SERVICE NOTES WERE NOT AVAILABLE TO DATE. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING AN ERRONEOUSLY HIGH TROPONIN (ACCUTNI) RESULT GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN. UPON REPEAT ON THIS AND ON A DIFFERENT INSTRUMENT, THE RESULTS WERE WITHIN THE NORMAL REFERENCE 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 MMI BECKMAN COULTER INC. ACCESS® 2 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1