BEUDAMED
    FDA Adverse Event Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1894513 · Received November 9, 2010

    Report

    Report Number
    2122870-2010-00714
    Date Received
    November 9, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE CUSTOMERS ESTABLISHED RANGES PRE AND POST THE EVENT. QC WAS NOT PREFORMED AFTER THE NO VALUE/ND FLAGS WERE RECEIVED HOTLINE INSTRUCTED THE CUSTOMER TO VERIFY THE LOCATION OF THE CK-MB REAGENT PACK. DURING TROUBLESHOOTING, THE CUSTOMER FOUND ONE CK-MB REAGENT PACK NOT IN THE PROPER LOCATION ON THE SYSTEM. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. 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 NO VALUE WITH INDETERMINATE (IND) FLAGS ON SEVERAL PATIENT'S SAMPLE FOR CK-MB GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1