BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 1832419 · Received September 13, 2010

    Report

    Report Number
    2122870-2010-00525
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 12, 2010
    Report Date
    September 10, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN LI HEPARIN PST TUBES, AND WERE CENTRIFUGED FOR 5 MINUTES AT 4500 RPM. QC PERFORMED AFTER THE EVENT WAS SUPPRESSED. THE CUSTOMER PERFORMED A SYSTEM CHECK AFTER THE EVENT, AND THE RESULTS MET SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2010. FSE REPLACED AND REBUILT SOME PARTS, AND PERFORMED HARDWARE VERIFICATION PROTOCOL. THE RESULTS MET THE SPECIFICATIONS. FSE ALSO PERFORMED QC AFTER REPLACING THE REAGENT PACK AND THE RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES. ALTHOUGH SOME HARDWARE ISSUES WERE ADDRESSED, NO DEFINITIVE ROOT CAUSE FOR THE EVENT HAS BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW TROPONIN (ACCUTNI) RESULTS IN THE NORMAL REFERENCE RANGE GENERATED ON ACCESS 2 IMMUNOASSAY SYSTEM FOR 4 PATIENT SAMPLES. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. UPON REPEAT TESTING ON AN ALTERNATE INSTRUMENT, THE RESULTS WERE WITHIN THE RISK STRATIFICATION RANGE. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1