BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3183384 · Received June 21, 2013

    Report

    Report Number
    2122870-2013-00559
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S BIOMEDICAL ENGINEERS DETERMINED HARDWARE ISSUES ON THE INSTRUMENT. THE BIOMEDICAL ENGINEERS REPLACED THE WASH PUMP MANIFOLD, ROTOR, AND STATOR AND RESOLVED THE HARDWARE ISSUES. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE TROPONIN I (ACCESS ACCUTNI) RESULTS, FOR SEVEN PATIENTS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. SUBSEQUENT ANALYSES OF THE PATIENTS¿ SAMPLES, ON THE SAME INSTRUMENT, RECOVERED NORMAL RESULTS. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. AMENDED RESULTS WERE REPORTED TO THE PHYSICIAN. THE CUSTOMER INDICATED THE LABORATORY HAS A STANDARD PROTOCOL TO RETEST TROPONIN I RESULTS GREATER THAN 0.1 NG/ML. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283455 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1