BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2012515 · Received March 9, 2011

    Report

    Report Number
    2122870-2011-00618
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    Z-0607-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE SERUM COLLECTED IN SST TUBES. WHILE THE CUSTOMER WAS TROUBLESHOOTING (TS) WITH AN ASSAY SPECIALIST A TBHCG REAGENT PACK WAS FOUND TO HAVE BEEN SHARED BETWEEN THE CUSTOMER'S TWO ACCESS SYSTEMS. WHEN THIS OCCURS THE INSTRUMENT DOES NOT DETECT THAT THE PACK TEST COUNT IS INCORRECT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS USE ERROR IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO OBTAINING A TBHCG (TOTAL BETA - HUMAN CHORIONIC GONADOTROPIN) RESULT OF 0 AND NO VALUE WITH IND FLAGS ON FOUR PATIENTS' SAMPLES GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. UPON REPEAT, THE CUSTOMER LOADED A NEW REAGENT PACK INTO THE INSTRUMENT AND RESULTS WERE OBTAINABLE. NO 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 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