BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 17783046 · Received September 20, 2023

    Report

    Report Number
    1225673-2023-00006
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 23, 2023
    Report Date
    September 20, 2023
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A COLLABORATIVE INVESTIGATION WAS COMPLETED BY DATA INNOVATIONS (MANUFACTURER), ABBOTT LABORATORIES (DISTRIBUTOR), AND WEST VIRGINIA UNIVERSITY MEDICAL CENTER (FACILITY). INVESTIGATION WITH THE FACILITY DETERMINED THAT THE TROPONIN UNITS SHOULD HAVE BEEN REPORTED OUT AS NG/L BUT INSTEAD WERE BEING REPORTED TO THE LABORATORY INFORMATION SYSTEM (LIS) AS NG/ML. DURING A REVIEW OF THE LABORATORY INSTRUMENT CONFIGURATION, IT WAS FOUND THAT THE INCORRECT UNIT VALUE OF NG/ML WAS CONFIGURED, WHICH RESULTED IN LABORATORY RESULTS BEING SENT WITH THE INCORRECT UNITS TO THE LIS. THE INVESTIGATION FOUND THAT THE SITE HAD RECENTLY COMPLETED AN UPGRADE PROJECT TO MOVE THE FACILITY FROM ONE INSTANCE OF INSTRUMENT MANAGER (IM) TO ANOTHER INSTANCE. THE SITE INDICATED THAT DURING THE UPGRADE PROCESS THERE WAS NOT ADEQUATE TIME TO COMPLETE TESTING BEFORE GOING LIVE. THE INVESTIGATION ALSO DETERMINED THAT A RULE (USER FACILITY PROGRAMMED LOGIC) WAS IN PLACE TO SET AN ERROR CODE INDICATING THAT UNITS DO NOT MATCH. A SEPARATE RULE TO HOLD RESULTS USED BY THE FACILITY WAS NOT CONFIGURED TO INCLUDE HOLDING RESULTS WHEN THE UNITS DO NOT MATCH. THIS IS NOT A MALFUNCTION OF THE INSTRUMENT MANAGER MEDICAL DEVICE. THIS IS THE RESULT OF A CONFIGURATION ERROR. THE FACILITY INDICATED THAT 37 PATIENTS HAD TROPONIN LEVEL REPORTED AT A LEVEL LOWER THAN ACTUAL BY 1000X, OF WHICH FOUR (4) PATIENTS WITH TROPONIN ELEVATION INDICATING CARDIAC INJURY (BUT REPORTED AS NORMAL) WERE NOT PROPERLY DIAGNOSED AND TREATED, AND ELEVEN (11) PATIENTS WITH TROPONIN ELEVATION INDICATING POSSIBLE CARDIAC INJURY (BUT REPORTED AS NORMAL) WILL NEED FURTHER FOLLOW UP TO DETERMINE CLINICAL IMPACT. ADDITIONALLY, ELEVEN (11) PATIENTS WITH TROPONIN ELEVATION INDICATING CARDIAC INJURY (BUT REPORTED AS NORMAL) WERE PROPERLY DIAGNOSED AND TREATED DESPITE THE INCORRECT REPORTING, AND AN ADDITIONAL ELEVEN (11) PATIENTS HAD AN INCORRECT REPORTING OF TROPONIN WITH NO CLINICAL IMPACT.

    Description of Event or Problem · 0

    A REPRESENTATIVE FROM A RESELLER REPORTED ON 23 AUGUST 2023 THAT TROPONIN RESULTS WERE SENT TO THE LABORATORY INFORMATION SYSTEM (LIS) WITH THE INCORRECT UNITS. THE TROPONIN UNITS SHOULD HAVE BEEN REPORTING OUT AS NG/L BUT INSTEAD WERE REPORTED AS NG/ML. THIS ISSUE RESULTED IN 37 PATIENTS HAVING THE TROPONIN LEVEL REPORTED AT A LEVEL LOWER THAN ACTUAL BY 1000X.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87656 INSTRUMENT MANAGER SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP DATA INNOVATIONS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown