BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2383081 · Received December 20, 2011

    Report

    Report Number
    2122870-2011-06428
    Event Type
    Injury
    Date Received
    December 20, 2011
    Date of Event
    October 23, 2011
    Report Date
    November 22, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Adverse Event
    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. 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; CATALOGUE NUMBER: A63254, (B)(4), 510(K) NUMBER: K023049, DEVICE MANUFACTURE DATE: 09/11/2000. SYNCHRON LX I 725 CLINICAL SYSTEM. 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

    THE CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT OBTAINING REPRODUCIBLE ELEVATED TROPONIN I (ACCUTNI) RESULTS FOR ONE (1) PATIENT. THE CUSTOMER SWITCHED THE INSTRUMENT FROM SYNCHRON LXI 725 CLINICAL SYSTEM TO UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM, AND IT IS UNKNOWN WHICH RESULTS WERE OBTAINED FROM WHICH INSTRUMENT. THIS REPORT DOCUMENTS RESULTS, WITHIN THE RISK STRATIFICATION AND ABOVE THE ACUTE MYOCARDIAL INFARCTION THRESHOLD, GENERATED ON (B)(6) 2011. PATIENT SAMPLE TESTED ON AN ALTERNATE METHODOLOGY GAVE A "NEGATIVE" TROPONIN RESULT. THE RESULTS WERE REPORTED OUT OF THE LABORATORY, BUT DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT UNDERWENT A CATHETERIZATION PROCEDURE IN CONNECTION TO THE ERRONEOUSLY ELEVATED RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention