BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2080842 · Received May 6, 2011

    Report

    Report Number
    2122870-2011-01263
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WERE NOT SUPPLIED. CUSTOMER DID NOT FOLLOW THE OUTLINED PROCEDURE FOR LOADING A NEW REAGENT PACK ON THE SYSTEM. SERVICE WAS NOT DISPATCHED, AS CUSTOMER WAS NOT QUESTIONING INSTRUMENT PERFORMANCE. ROOT CAUSE IS ASSOCIATED WITH USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A REAGENT PACK MIS-LOAD THAT LED TO THREE (3) ERRONEOUS TRONPONIN (ACCUTNI) RESULTS ON THE ACCESS 2 IMMUNOASSAY SYSTEM. ALL THREE (3) RESULTS WERE REPORTED OUT OF THE LABORATORY. REPEAT ANALYSIS OF SAMPLES WERE PERFORMED AND REPORTS WERE AMENDED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1