BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1838487 · Received September 17, 2010

    Report

    Report Number
    2122870-2010-00544
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 20, 2010
    Report Date
    September 17, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TYPICALLY REPORTS TESTOSTERONE RESULTS AS NG/DL. THE INITIAL RESULTS WERE REPORTED IN NG/ML AND WERE MISINTERPRETED AS ERRONEOUS. PER THE CUSTOMER, THE TESTOSTERONE SAMPLES ARE COLLECTED OFF-SITE IN 10X75MM PLASTIC SERUM TUBES. PER THE CUSTOMER SUPPLIED CHARTS, ALL THREE LEVELS OF TESTOSTERONE QC RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND ON THE DAY OF THE EVENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE LIKELY ROOT CAUSE WAS DISCOVERED WHILE TROUBLESHOOTING (TS) WITH CUSTOMER TECHNICAL SUPPORT (CTS).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING LOWER THAN EXPECTED TESTOSTERONE RESULTS WHICH APPEARED TO BELOW THE NORMAL REFERENCE RANGE FOR FIVE PATIENTS THAT WAS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE SUBSEQUENT TESTING PRODUCED SIGNIFICANTLY HIGHER RESULTS FOR ALL THE FIVE PATIENTS. AFTER REVIEW OF THE RESULTS IT WAS DETERMINED THAT ALL OF THE INITIAL VALUES TO BE CORRECT AS THE REPORTING UNITS HAS BEEN CHANGED FROM NG/DL TO NG/ML. 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 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 800 009240

    Patients

    Seq Age Sex Outcome Treatment
    1