BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2387336 · Received December 22, 2011

    Report

    Report Number
    2122870-2011-06432
    Event Type
    Malfunction
    Date Received
    December 22, 2011
    Date of Event
    October 11, 2011
    Report Date
    November 22, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHANGE BULLET POINT #2 FROM: THIS REPORT DOCUMENTS A RESULT, ABOVE THE ACUTE MYOCARDIAL INFARCTION CUTOFF OF THE ASSAY, GENERATED ON (B)(6) 2011 FOR ONE (1) PATIENT. THE CUSTOMER FELT THE ACCUTNI PATIENT SAMPLES WERE DISCORDANT TO ALTERNATE METHOD TESTING. PATIENT RESULTS ARE PROVIDED. TO: THIS REPORT DOCUMENTS A RESULT, WITHIN THE RISK STRATIFICATION RANGE OF THE ASSAY, GENERATED ON (B)(6) 2011 FOR ONE (1) PATIENT. THE CUSTOMER FELT THE ACCUTNI PATIENT SAMPLES WERE DISCORDANT TO ALTERNATE METHOD TESTING. PATIENT RESULTS ARE PROVIDED. ADD THE FOLLOWING: 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.

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE BASED ON THE SUPPLIED INFORMATION. NOTE: THIS REPORT CONTAINS INFORMATION ON THE CUSTOMER'S UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM ONLY. 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). THE 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

    THIS REPORT DOCUMENTS A RESULT, WITHIN THE RISK STRATIFICATION RANGE OF THE ASSAY, GENERATED ON (B)(6) 2011 FOR ONE (1) PATIENT. THE CUSTOMER FELT THE ACCUTNI PATIENT SAMPLES WERE DISCORDANT TO ALTERNATE METHOD TESTING. PATIENT RESULTS ARE PROVIDED.

    Description of Event or Problem · 1

    THE 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 INSTRUMENT. THIS REPORT DOCUMENTS A RESULT, ABOVE THE ACUTE MYOCARDIAL INFARCTION CUTOFF OF THE ASSAY, GENERATED ON (B)(6) 2011 FOR ONE (1) PATIENT. THE CUSTOMER FELT THE ACCUTNI PATIENT SAMPLES WERE DISCORDANT TO ALTERNATE METHOD TESTING. 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 CHANGE 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 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXI 600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1