BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 3100854 · Received May 8, 2013

    Report

    Report Number
    2122870-2013-00446
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. ALTHOUGH THE CUSTOMER'S REPEAT PROCEDURE RESOLVED THE ISSUE, A DEFINITIVE CAUSE OF THE EVENT COULD NOT BE DETERMINED. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2122870-2013-00443, 2122870-2013-00444, 2122870-2013-00445, 2122870-2013-00446.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED NON-REPRODUCIBLE FALSE POSITIVE TROPONIN I (ACCESS ACCUTNI) RESULTS, ON SEPARATE DAYS, INVOLVING THE ACCESS 2 IMMUNOASSAY ANALYZER PORTION OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER INDICATED THAT THE DISCREPANT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. REPEAT TESTING OF THE SAMPLES ON AN ALTERNATE ANALYZER PRODUCED ACCUTNI RESULTS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY AND RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER STATED THAT ABOUT ONE (1) SAMPLE PER MONTH WERE INITIALLY POSITIVE BUT NEGATIVE UPON REPEAT. THE CUSTOMER HAS IMPLEMENTED A PROCEDURE TO RUN ALL ACCUTNI PATIENT SAMPLES IN DUPLICATE AND SAMPLES ARE REPEATED IN DUPLICATE ON AN ALTERNATE ANALYZER IF THERE IS ANY DISCREPANCY BETWEEN THE FIRST DUPLICATE RESULTS. THE EVENT WAS REPORTED AS PART OF BECKMAN COULTER MARKETING SURVEY PROGRAM (MSP) FOR ACCUTNI. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION INDICATING AN INCREASE IN OCCURRENCE OR AN INSTRUMENT MALFUNCTION. THIS REPORT REFERENCES THE EVENT WHICH OCCURRED ON (B)(6) 2013. THE CUSTOMER DID NOT SUPPLY CALIBRATION, QC (QUALITY CONTROL), OR SYSTEM CHECK INFORMATION. THE CUSTOMER USES BOTH SERUM AND HEPARINIZED PLASMA SAMPLES. ACCUTNI REAGENTS PART NUMBER A78803 WERE USED IN CONJUNCTION WITH THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201529 UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1