BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMNOASSAY SYSTEM

    MDR report key: 1200190 · Received September 24, 2008

    Report

    Report Number
    2122870-2008-00301
    Event Type
    Other
    Date Received
    September 24, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS BEFORE THE ERRONEOUS RESULTS. CUSTOMER STATES THE ULTRASONIC ERRORS WERE OCCURRING ON A REAGENT PIPETTOR AND THE REAGENT PIPETTOR WAS DRIPPING. CUSTOMER DISABLED THAT REAGENT PIPETTOR AND RETESTED THE SAMPLES IN QUESTION ON THE OTHER PIPETTORS. A FIELD SERVICE ENGINEER (FSE) WAS ON SITE IN 2008: FSE DISCOVERED THAT THE TUBING FOR A REAGENT PIPETTOR HAD A HOLE IN IT AND A TRANSDUCER WIRE WAS BROKEN. FSE REPLACED THE TUBING AND THE TRANSDUCER, PERFORMED ALL ULTRASONIC TESTING AND CALIBRATED THE PRESSURE SENSORS. HARDWARE VERIFICATION TESTING WAS PERFORMED AND ALL PASSED WITHIN PUBLISHED SPECIFICATIONS. EVEN THOUGH TSH AND FERRITIN RESULTS ARE UNLIKELY TO BE THE BASIS TO INITIATE OR WITHHOLD TREATMENT, IN THIS EVENT THE HARDWARE FAILURES COULD HAVE AFFECTED OTHER PIVOTAL ASSAYS. DUE TO A POTENTIAL FOR THIS EVENT TO RECUR UNKNOWINGLY, THERE IS POTENTIAL THAT A PIVOTAL ASSAY COULD BE ERRONEOUSLY REPORTED AND TREATMENT DECISION MAY BE AFFECTED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW TSH AND FERRITIN RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. A SAMPLE FROM THE FIRST PATIENT WHEN TESTED GAVE TSH RESULTS OF 0.04 AND 0.05 UI/ML. UPON REPEAT, IT GAVE A RESULT OF 4.20IU/ML. A SAMPLE OBTAINED FROM ANOTHER PATIENT GAVE A TSH RESULT OF 0.0IU/ML AND UPON RE-TESTING IT GAVE A RESULT OF 3.88IU/ML. A THIRD PATIENT WAS TESTED AND GAVE A FERRITIN RESULT OF 0.0NG/ML AND REPEATED AT 95.4NG/ML. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND CORRECTED REPORTS WERE ISSUED. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN RECEIVED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA