BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® ACCUTNI

    MDR report key: 3771789 · Received April 24, 2014

    Report

    Report Number
    2122870-2014-00295
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 29, 2014
    Report Date
    March 30, 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.

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED FALSE POSITIVE TROPONIN I (ACCESS® ACCUTNI) RESULT, WITHIN THE RISK STRATIFICATION, FOR ONE PATIENT, INVOLVING THE ACCESS® ACCUTNI REAGENT USED IN CONJUNCTION WITH THE UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM. AN INITIAL RESULT OF 0.093 UG/L WAS OBTAINED AND RELEASED FROM THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. SUBSEQUENT TESTING OF THE PATIENT'S SAMPLE (CENTRIFUGED ALIQUOT), ON THE SAME INSTRUMENT, GENERATED LOWER RESULTS OF 0.039 UG/L AND 0.042 UG/L. THE CUSTOMER ISSUED AN AVERAGE RESULT OF 0.041 UG/L TO THE HOSPITAL. DATA ANALYSIS INDICATED QUALITY CONTROL (QC), CALIBRATIONS, AND SYSTEM CHECKS WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS. THE PATIENT'S SAMPLE WAS CENTRIFUGED AT 4,000 RPM (ROTATIONS PER MINUTE) FOR FIVE MINUTES, AT 19 DEGREES CELSIUS LABORATORY TEMPERATURE. THE SAMPLE WAS ANALYZED FROM THE PRIMARY TUBE. NO SAMPLE INTEGRITY ISSUES WERE NOTED AND NO SYSTEM ERRORS WERE REPORTED AT THE TIME OF THE ANALYSIS. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249676 ACCESS® ACCUTNI IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 336236

    Patients

    Seq Age Sex Outcome Treatment
    1