BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS ACCUTNI

    MDR report key: 3945523 · Received July 21, 2014

    Report

    Report Number
    2122870-2014-00522
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE ACCESS ACCUTNI DEVICE WAS RETURNED FOR EVALUATION. SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. IN CONCLUSION, A DEFINITIVE CAUSE OF THE INCIDENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2014-00523.

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED FALSELY ELEVATED INITIAL TROPONIN I (ACCESS ACCUTNI) RESULTS, ABOVE THE NORMAL REFERENCE RANGE, FOR TWO PATIENTS, INVOLVING THE ACCESS ACCUTNI ASSAY USED IN CONJUNCTION WITH THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. THIS REPORT IS ONE OF TWO REFERENCING THE PATIENT ON THE EVENT DATE NOTED. AN INITIAL RESULT OF 0.051 UG/L WAS OBTAINED AND RELEASED OUT OF THE LABORATORY. THE CUSTOMER REANALYZED THE SAMPLE, ON THE SAME INSTRUMENT, AND OBTAINED LOWER RESULTS OF 0.029 AND 0.030 UG/L. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE PATIENT'S SAMPLE WAS CENTRIFUGED AT 3,000G (RELATIVE CENTRIFUGAL FORCE) FOR TEN MINUTES, AT 20 DEGREES CELSIUS. NO SAMPLE INTEGRITY ISSUES WERE NOTED. THE CUSTOMER INDICATED ALL OF THE SYSTEM PARAMETERS (QUALITY CONTROL, CALIBRATION, AND SYSTEM CHECK) WERE WITHIN SPECIFICATIONS. THE INSTRUMENT WAS IN NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424643 ACCESS ACCUTNI IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 336838

    Patients

    Seq Age Sex Outcome Treatment
    1