BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1933541 · Received December 21, 2010

    Report

    Report Number
    2122870-2010-00952
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LFX
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION BY THE CUSTOMER THAT SERVICE WAS DISPATCHED FOR THIS EVENT. NO CLEAR ROOT CAUSE HAS BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING REACTIVE RUBELLA IGM RESULTS FOR TWO (2) PATIENTS THAT WERE DISCORDANT TO AN ALTERNATE METHOD THAT WAS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. THIS REPORT IS BEING SUBMITTED FOR PATIENT #2 RESULTS ASSOCIATED WITH THIS EVENT. A SEPARATE MDR 2122870-2010-00953 WAS SUBMITTED FOR THE MALFUNCTION AND PATIENT #1 RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other