BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1903946 · Received November 20, 2010

    Report

    Report Number
    2122870-2010-00795
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 8, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A ROUTINE SYSTEM CHECK WAS PERFORMED, BY THE CUSTOMER, ON (B)(6) 2010 WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THERE IS NO INDICATION THAT SERVICE WAS DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY LOW ESTRADIOL RESULTS OF 0 PG/ML FOR MULTIPLE PATIENTS. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED HIGHER RESULTS IN A DIFFERENT CLINICAL CATEGORY FOR ALL AFFECTED PATIENTS. 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 UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1