BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS ACCUTNI+3 REAGENT

    MDR report key: 4182917 · Received October 17, 2014

    Report

    Report Number
    2122870-2014-00722
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 24, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K121214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE ACCESS ACCUTNI+3 DEVICE WAS RETURNED FOR EVALUATION. THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE ASPIRATE PROBES WERE NOT PROPERLY CONNECTED AND RECONNECTED PROPERLY. THIS FINDING IS UNLIKELY TO HAVE CONTRIBUTED TO THE EVENT AS THE ISSUE WOULD BE SYSTEMIC; THE CUSTOMER ONLY QUESTIONED RESULTS FOR ONE PATIENT. NO OTHER SYSTEM ISSUES THAT COULD HAVE CONTRIBUTED TO THE EVENT WERE IDENTIFIED. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, A DEFINITIVE CAUSE OF THE INCIDENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT TROPONIN I (ACCESS ACCUTNI+3) RESULTS, FOR ONE PATIENT, INVOLVING THE ACCESS ACCUTNI+3 REAGENT USED IN CONJUNCTION WITH THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE SAMPLE WAS AUTOMATICALLY RETESTED (REFLEXED). THE CUSTOMER HAS A PROTOCOL TO RETEST ALL SAMPLES WITH CRITICAL TROPONIN I RESULTS. THE POLICY STATES THAT IF BOTH THE INITIAL AND RETEST RESULTS WERE CRITICAL, THEN TO RELEASE THE FIRST CRITICAL RESULT, THUS A RESULT OF 0.13 NG/ML WAS RELEASED TO THE PHYSICIAN. THE CUSTOMER HAS NOT RECEIVED ANY REPORT OF IMPACT TO PATIENT CARE. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS INCIDENT. THE PATIENT'S SAMPLES WERE COLLECTED IN 13X100 MM LITHIUM HEPARIN GEL TUBES AND CENTRIFUGED AT 3,000 RPM (ROTATIONS PER MINUTE) FOR TEN MINUTES, AT ROOM TEMPERATURE. THE CUSTOMER STATED NO SAMPLE INTEGRITY ISSUES WERE NOTED. A REVIEW OF THE CUSTOMER'S QUALITY CONTROL (QC) DATA INDICATES QUALITY CONTROL WAS WITHIN THE LABORATORY'S EXPECTED RANGES AT THE TIME OF THE EVENT. NO SYSTEM ISSUES WERE NOTED. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661420 ACCESS ACCUTNI+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 424125

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR