BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1972163 · Received January 27, 2011

    Report

    Report Number
    2122870-2011-00155
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSTEM CHECK WAS PERFORMED ON (B)(4) 2010 AND MET SPECIFICATIONS. THE CUSTOMER CONTACTED CUSTOMER TECHNICAL SUPPORT AND ALSO MENTIONED THAT THE SYSTEM WAS GENERATING REAGENT CAROUSEL MOTION ERRORS WHILE LOADING A NEW ACCUTNI REAGENT PACK ON TO THE INSTRUMENT. CTS HAD THE CUSTOMER UNLOAD THE ACCUTNI REAGENT. THE CUSTOMER FOUND THAT THE REAGENT PACK WAS MISLOADED AND THEREFORE IN THE INCORRECT SLOT OF THE REAGENT STORAGE CAROUSEL. WHEN THIS OCCURS THE INSTRUMENT DOES NOT DETECT EITHER A WRONG REAGENT PACK OR NO REAGENT PACK PRESENT. THE CUSTOMER REMOVED THE MISLOADED REAGENT PACK, DELETED THE PACK FROM THE REAGENT INVENTORY, AND DISCARDED IT. USER ERROR IS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING NO VALUE RESULTS WITH INDETERMINANT (IND) FLAGS FOR TWO PATIENTS' SAMPLES WHEN BEING ANALYZED FOR TROPONIN (ACCUTNI) ON THE ACCESS 2 IMMUNOASSAY SYSTEM. REPEAT TESTING ON AN ALTERNATE INSTRUMENT RESULTED WITH ONE PATIENT IN THE NORMAL REFERENCE RANGE AND THE SECOND PATIENT RESULTING IN THE RISK STRATIFICATION RANGE. 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 JJE BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1