BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS ACCUTNI

    MDR report key: 4133655 · Received October 1, 2014

    Report

    Report Number
    2122870-2014-00680
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    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. TESTING OF THE CUSTOMER-SUPPLIED NEAT SAMPLE CONFIRMED THE CUSTOMERS RESULTS. FURTHER TESTING OF THE SAMPLE, WITH A BLOCKER PROTEIN SPECIFIC TO ALKALINE PHOSPHATASE (AP MUTEIN), REDUCED THE ELEVATED RESULT BY 89.8%, CONFIRMING THE PRESENCE OF A PATIENT SOURCE INTERFERENT LIKELY RELATED TO ALKALINE PHOSPHATASE. IN CONCLUSION, THE CAUSE OF THE ELEVATED TROPONIN I RESULTS IS DUE TO A PATIENT SOURCE INTERFERENT LIKELY RELATED TO ALKALINE PHOSPHATASE. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2014-00679.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT TROPONIN I (ACCESS ACCUTNI) RESULTS, FOR ONE PATIENT, INVOLVING THE ACCESS ACCUTNI ASSAY USED IN CONJUNCTION WITH THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THIS REPORT IS TWO OF TWO REFERENCING THE EVENT DATE NOTED. AN ELEVATED INITIAL RESULT OF 1.12 NG/ML WAS OBTAINED AND RELEASED FROM THE LABORATORY. AS A RESULT, THE PATIENT WAS TRANSFERRED TO AN ALTERNATE FACILITY. IT IS UNKNOWN IF ANY ADDITIONAL TREATMENT WAS GIVEN TO THE PATIENT. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. THE CUSTOMER STATED SUBSEQUENT TESTING OF THE PATIENT'S SAMPLE, ON AN ALTERNATE METHODOLOGY, GENERATED A NORMAL RESULT (ACTUAL VALUE NOT PROVIDED). THE PATIENT'S SAMPLE WAS COLLECTED IN A 3 ML LITHIUM HEPARIN TUBE AND CENTRIFUGED FOR SEVEN MINUTES. NO SAMPLE INTEGRITY ISSUES WERE REPORTED. ALL SYSTEM PARAMETERS, INCLUDING QUALITY CONTROL, CALIBRATIONS, AND SYSTEMS CHECKS, WERE WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS. NO SYSTEM ISSUES WERE NOTED. THE INSTRUMENT WAS IN NORMAL OPERATION. THE CUSTOMER SENT THE PATIENT'S SAMPLE TO BECKMAN COULTER FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612463 ACCESS ACCUTNI IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 336766

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization