BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2365410 · Received December 9, 2011

    Report

    Report Number
    2122870-2011-06307
    Event Type
    Malfunction
    Date Received
    December 9, 2011
    Date of Event
    July 22, 2011
    Report Date
    November 9, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION DEVICE AND CENTRIFUGATION INFORMATION HAVE NOT BEEN SUPPLIED TO DATE. QC, SYSTEM CHECK, AND SERVICE INFORMATION HAVE NOT BEEN SUPPLIED TO DATE FOR THIS EVENT. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. THIS EVENT IS RELATED TO THE EVENT REPORTED IN MDR #2122870-2011-06322.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT OBTAINING ERRONEOUSLY ELEVATED TROPONIN I (ACCUTNI) RESULTS, ABOVE THE AMI CUTOFF, FROM UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TWO PATIENTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING PRODUCED A LOWER RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE PATIENT AND RE-PRODUCED A RESULTS ABOVE THE AMI CUTOFF, DISCORDANT TO AN ALTERNATE METHOD, FOR THE OTHER PATIENT. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1