BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 14503883 · Received May 26, 2022

    Report

    Report Number
    1225673-2022-00004
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 25, 2022
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A COLLABORATIVE INVESTIGATION IS BEING COMPLETED BY DATA INNOVATIONS (MANUFACTURER) AND (B)(6) HEALTH SYSTEM CORPORATION - (B)(6) (CUSTOMER) AND IS IN PROGRESS AT THE TIME OF THIS REPORT. ON (B)(6) 2022, DATA INNOVATIONS WAS NOTIFIED OF AN INCIDENT RELATED TO OUR PRODUCT, INSTRUMENT MANAGER. THE INCIDENT WAS THAT RESULTS FOR TROPONIN T WERE ERRONEOUSLY AUTO-FILED TO THE PATIENT CHART DUE TO THERE BEING NO HEMOLYSIS (HIL) RESULTS. TROPONIN T IS FALSELY DEPRESSED BY HEMOLYSIS, SO A FALSELY LOW TROPONIN T COULD BE RELEASED IN ERROR. THE TECHNICIAN OBSERVED THE HEMOLYSIS INDEX WAS TOO HIGH FOR TROPONIN WHEN REVIEWING OTHER CHEMISTRY RESULTS ON THE SAME PATIENT. THERE WAS NO PATIENT HARM AS THE INCORRECT RESULTS WERE REMOVED FROM THE PATIENT CHART AND THE FLOOR/RN WAS NOTIFIED OF THE ERROR. THE PATIENT WAS REDRAWN AND NO HARM OR MEDICAL DECISION WAS MADE BASED ON THE ERRONEOUS RESULT. THE CUSTOMER HAS PROVIDED DATA FOR USE IN THE INVESTIGATION, HOWEVER IT IS INSUFFICIENT TO DETERMINE THE ROOT CAUSE AND THEREFORE, THE INVESTIGATION HAS NOT YET DETERMINED IF THIS IS MALFUNCTION OF THE INSTRUMENT MANAGER SOFTWARE AND IS ONGOING AT THE TIME OF THIS REPORT. AS ADDITIONAL INFORMATION IS RECEIVED TO COMPLETE THE INVESTIGATION AND MAKE A FINAL DETERMINATION, AN UPDATE TO THIS REPORT WILL BE FILED AT THAT TIME.

    Description of Event or Problem · 0

    A LABORATORY USER REPORTED ON (B)(6) 2022 THAT RESULTS FOR TROPONIN T WERE ERRONEOUSLY AUTO-FILED TO THE PATIENT CHART DUE TO THERE BEING NO HEMOLYSIS (HIL) RESULTS. TROPONIN T IS FALSELY DEPRESSED BY HEMOLYSIS, SO A FALSELY LOW TROPONIN T COULD BE RELEASED IN ERROR. THE TECHNICIAN OBSERVED THE HEMOLYSIS INDEX WAS TOO HIGH FOR TROPONIN WHEN REVIEWING OTHER CHEMISTRY RESULTS ON THE SAME PATIENT. THERE WAS NO PATIENT HARM AS THE INCORRECT RESULTS WERE REMOVED FROM THE PATIENT CHART AND THE FLOOR/RN WAS NOTIFIED OF THE ERROR. THE PATIENT WAS REDRAWN AND NO HARM OR MEDICAL DECISION WAS MADE BASED ON THE ERRONEOUS RESULT. INITIAL DATA RECEIVED FROM THE CUSTOMER FOR USE IN THE INVESTIGATION HAS NOT BEEN ABLE TO IDENTIFY A ROOT CAUSE, AND THEREFORE IT IS NOT YET DETERMINED WHETHER OR NOT THIS WAS A MALFUNCTION OF THE INSTRUMENT MANAGER SOFTWARE. THE INVESTIGATION IS ONGOING AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1890998 INSTRUMENT MANAGER SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP DATA INNOVATIONS LLC 8.13.00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown