BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2230277 · Received September 1, 2011

    Report

    Report Number
    2122870-2011-03154
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BEC HOTLINE ASSISTED THE CUSTOMER IN REPLACING THE SHARED REAGENT PACK WITH A NEW REAGENT PACK. THE CUSTOMER PERFORMED QC WITHIN THE LABORATORY'S ESTABLISHED RANGES AFTER LOADING THE NEW REAGENT PACK. SERVICE WAS NOT DISPATCHED FOR THIS EVENT TO DATE. USE ERROR IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO TROUBLESHOOT EVENT LOG ERRORS AND BHCG (BETA - HUMAN CHORIONIC GONADOTROPIN) QC RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. IT WAS DETERMINED THAT THE INSTRUMENT WAS SHARING AN ON BOARD BHCG REAGENT PACK WITH ANOTHER INSTRUMENT. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO 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