BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2120889 · Received June 12, 2011

    Report

    Report Number
    2122870-2011-01856
    Event Type
    Malfunction
    Date Received
    June 12, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE AND PATIENT INFORMATION WAS NOT PROVIDED. THE CUSTOMER OBTAINED IND FLAGS ON LEVEL 1 AND LEVEL 3 ACCUTNI QC. ON (B)(4)-2011 A BCI FIELD SERVICE ENGINEER (FSE) NOTED THAT THE CUSTOMER INCORRECTLY LOADED THE REAGENT PACK IN THE WRONG PLACE FSE REMOVED AND DISCARDED THE REAGENT PACK. USER ERROR IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO RECEIVING AN INDETERMINATE (IND) FLAGS ON ONE PATIENT'S ACCUTNI RESULT AND QC RESULTS WHICH WERE GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED ON AN ALTERNATE UNIT AND RESULT WITHIN RANGE WAS OBTAINED. 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