BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2340941 · Received November 17, 2011

    Report

    Report Number
    2122870-2011-05429
    Event Type
    Malfunction
    Date Received
    November 17, 2011
    Date of Event
    October 18, 2011
    Report Date
    October 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND SPECIFIC CENTRIFUGATION DATA WAS NOT SUPPLIED. NO SPECIFIC EVENT QC DATA WAS SUPPLIED. THE LABORATORY HAS AN ACCUTNI PATIENT SAMPLE REPEAT ANALYSIS PROCEDURE, WHICH INCLUDES RE-TESTING ALL INITIAL OR FIRST TIME ACCUTNI SAMPLE VALUES GREATER THAN 0.05NG/ML PRIOR TO RELEASING DATA. THE UNIT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS UPON CONTACT WITH THE CUSTOMER. THE CUSTOMER DID NOT PROVIDE INFORMATION INDICATING AN INCREASE IN OCCURRENCE OR AN INSTRUMENT MALFUNCTION. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A ROOT CAUSE FOR THIS EVENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER WAS CONTACTED BY BECKMAN COULTER, INC. (BEC) REGARDING THE ASSAY PERFORMANCE OF ACCESS ACCUTNI, AND INDICATED AN OCCURRENCE OF NON-REPRODUCIBLE FALSE POSITIVE TROPONIN (ACCUTNI) RESULT GENERATED BY UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ON ONE PATIENT'S SAMPLE. THE RESULT WAS REPORTED OUT OF THE LABORATORY. REPEAT TESTING PRODUCED A RESULT WITHIN THE NORMAL REFERENCE RANGE, AND THE REPORT WAS AMENDED IMMEDIATELY WITHIN 20 MINUTES. THE CUSTOMER STATED THAT THERE WAS NO INSTANCE OF DEATH, INJURY, SERIOUS MEDICAL DETERIORATION, OR INAPPROPRIATE MEDICAL TREATMENT BECAUSE OF THE INITIAL RESULT BEING REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1