BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1893519 · Received November 8, 2010

    Report

    Report Number
    2122870-2010-00712
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    September 22, 2010
    Report Date
    November 8, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN GREINER SST TUBES AND SPUN FOR 10 MINUTES AT 3338 RPM. PER CUSTOMER, SYSTEM CHECKS HAVE BEEN PASSING WITHIN SPECIFICATIONS. QC HAS BEEN RECOVERING WITHIN THE CUSTOMER'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2010. FSE ADDRESSED A NUMBER OF HARDWARE ISSUES AND REPLACED SOME HARDWARE. FSE VERIFIED ALL REPAIRS BY RUNNING A SYSTEM CHECK WHICH PASSED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRATIC TROPONIN (ACCUTNI) RESULTS WITHIN DIFFERENT CLINICAL RANGES FOR FOUR PATIENT SAMPLES GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. PATIENT #1'S SAMPLE RESULTED AS 0.78NG/ML AND REPEATED AT 0.24NG/ML WITHIN THE RISK STRATIFICATION RANGE. THE OTHER THREE PATIENTS' SAMPLES WERE IN THE RANGE OF 0.01-0.14NG/ML AND REPEATED IN THE RANGE OF 0.01-0.08NG/ML THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1