BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2387326 · Received December 22, 2011

    Report

    Report Number
    2122870-2011-06443
    Event Type
    Malfunction
    Date Received
    December 22, 2011
    Date of Event
    September 17, 2011
    Report Date
    November 22, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION DEVICE AND CENTRIFUGATION INFORMATION WAS NOT PROVIDED. QC AND SYSTEM CHECK DATA WAS NOT PROVIDED. ACCESS ACCUTNI REAGENT LOT NUMBER WAS NOT PROVIDED. THE CUSTOMER HAS SENT SOME OF THE PATIENT SAMPLES TO BEC FOR FURTHER INVESTIGATION: THE CUSTOMER'S ACCUTNI RESULTS WERE REPEATED BY TESTING AT BEC. INTERFERENCE TESTING REVEALED AN INTERFERENCE WHICH LIKELY RELATES TO ALKALINE PHOSPHATASE. THIS INTERFERING COMPOUND DISTINCT FROM HETEROPHILE ANTIBODIES CAUSES REPRODUCIBLE FALSE POSITIVE RESULTS. AS FOR HETEROPHILE ANTIBODIES INTERFERENCE, THE RESULTS DO NOT CORRELATE WITH THE CLINICAL STATUS OF THE PATIENT. NOTE: ACCESS ACCUTNI REAGENT, 2X50 DET: CATALOGUE NUMBER A78803, PRODUCT CODE MMI, 510(K) NUMBER K010429. THE INFORMATION ON THE CUSTOMER'S OTHER INSTRUMENT SYNCHRON LXI 725 CLINICAL SYSTEM IS LISTED BELOW: BRAND NAME: SYNCHRON LXI 725 CLINICAL SYSTEM, REFURBISHED, TYPE OF DEVICE: DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE, PRODUCT CODE: JJE, CATALOGUE NUMBER: A63254, SERIAL NUMBER: (B)(4), 510(K) NUMBER: K023049, DEVICE MANUFACTURE DATE: 09/11/2000. THE BELOW LISTED MDRS ARE BEING REPORTED FOR THE EVENTS ON DIFFERENT DATES AT THIS CUSTOMER SITE: 2122870-2011-06428, 2122870-2011-06429, 2122870-2011-06430, 2122870-2011-06431, 2122870-2011-06432, 2122870-2011-06433, 2122870-2011-06434, 2122870-2011-06435, 2122870-2011-06436, 2122870-2011-06437, 2122870-2011-06438, 2122870-2011-06439, 2122870-2011-06440, 2122870-2011-06441, 2122870-2011-06442, 2122870-2011-06443, 2122870-2011-06444, 2122870-2011-06445, 2122870-2011-06446, 2122870-2011-06447, 2122870-2011-06448.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT OBTAINING REPRODUCIBLE ELEVATED TROPONIN I (ACCUTNI) RESULTS OVER A PERIOD OF (B)(6) 2011. THE CUSTOMER SWITCHED THE INSTRUMENT FROM SYNCHRON LXI 725 CLINICAL SYSTEM TO UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM DURING THIS PERIOD, AND IT IS UNKNOWN WHICH RESULTS WERE OBTAINED FROM WHICH OF THESE TWO INSTRUMENTS. THIS REPORT DOCUMENTS A RESULT, ABOVE THE ACUTE MYOCARDIAL INFARCTION THRESHOLD, GENERATED ON (B)(6) 2011 FOR ONE (1) PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY, BUT DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT. IT IS UNKNOWN IF THERE WERE ANY CHANGES TO PATIENT TREATMENT IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE MMI BECKMAN COULTER, INC. DXI 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1