BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2080865 · Received May 6, 2011

    Report

    Report Number
    2122870-2011-01318
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNEXPECTED RESULTS OBTAINED THAT WERE NOT IN ALIGNMENT WITH CLINICAL PRESENTATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AFTER A PHYSICIAN QUESTIONED LOWER THAN EXPECTED TOTAL T4 (THYROXINE) RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES. THE LOWER THAN EXPECTED TOTAL T4 RESULTS WERE NOT IN ALIGNMENT WITH THE PATIENTS' CLINICAL PRESENTATIONS. THE CUSTOMER REPORTED THAT NORMAL RESULTS WERE OBTAINED FOR FREE T4 AND FOR TSH (THYROID STIMULATING HORMONE) FOR THE SAMPLES IN QUESTION. NONE OF THE SAMPLES WERE DRAWN FROM PREGNANT FEMALE PATIENTS. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION REGARDING THE NUMBER OF IMPACTED PATIENT SAMPLES, THE TYPE OF SAMPLES, OR THE RESULTS OBTAINED. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION REGARDING IF PATIENT TREATMENT WAS IMPACTED. A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE AND OBSERVED THAT THE INSTRUMENT EVENT LOG REVEALED NO ABNORMAL CONDITIONS. THE FIELD SERVICE ENGINEER OBSERVED A WORN VALVE AND THREE ASPIRATE PROBES WHICH APPEARED DIRTY. THE VALVE AND PROBES WERE REPLACED AND A SYSTEM CHECK CONFIRMED THE INSTRUMENT WAS OPERATING WITHIN SPECIFICATIONS. A ROOT CAUSE FOR THE LOWER THAN EXPECTED TOTAL T4 RESULTS HAS NOT YET BEEN DETERMINED.

    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. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS TOTAL T4 REAGENT| ACCESS TOTAL T4 CALIBRATORS