BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 15830958 · Received November 19, 2022

    Report

    Report Number
    1225673-2022-00016
    Event Type
    Malfunction
    Date Received
    November 19, 2022
    Date of Event
    October 20, 2022
    Report Date
    November 18, 2022
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A COLLABORATIVE INVESTIGATION WAS COMPLETED BY DATA INNOVATIONS (MANUFACTURER), ABBOTT LABORATORIES (DISTRIBUTOR), AND BAY CARE HEALTH SYSTEM (FACILITY). INVESTIGATION WITH THE FACILITY DETERMINED THAT THE FREE THYROXINE INDEX (FTI) CALCULATION WAS PRODUCING INCORRECT RESULTS AND THE RESULTS WERE NOT CROSSING FROM INSTRUMENT MANAGER (IM) TO THE LABORATORY INFORMATION SYSTEM (LIS). DURING REVIEW OF THE RULE (USER FACILITY PROGRAMMED LOGIC) THAT CALCULATES FTI, IT WAS DETERMINED THAT THE SPECIMEN ID VALUE THAT WAS SET FOR SPECIMEN USER FIELD (SUF) 09 WAS PULLING THE WRONG VALUE FOR SUF09 WHICH CAUSED THE INCORRECT RESULTS TO BE CALCULATED. THE DISTRIBUTOR WORKED WITH THE FACILITY TO FIX THE RULE TO PULL THE CORRECT VALUE FOR SUF09 AND THE FIX HAS BEEN CONFIRMED TO HAVE RESOLVED THE ISSUE. THIS IS NOT A MALFUNCTION OF INSTRUMENT MANAGER MEDICAL DEVICE. THIS INCIDENT IS DUE TO THE MISCONFIGURATION OF THE SPECIMEN USER FIELD WITHIN THE RULE THAT WAS CREATED BY ABBOTT LABORATORIES. THE FACILITY INDICATED 35 INCORRECT RESULTS WERE SENT TO THE LIS WHICH HAVE SINCE BEEN CORRECTED. IT IS UNKNOWN AT THIS TIME IF THERE WAS ANY PATIENT HARM DUE TO THE INCORRECT RESULTS.

    Description of Event or Problem · 0

    A REPRESENTATIVE FROM THE DISTRIBUTOR REPORTED ON (B)(6) 2022 THAT THE FREE THYROXINE INDEX (FTI) CALCULATION IS PRODUCING INCORRECT RESULTS AND THAT THE FTI RESULTS ARE NOT CROSSING FROM INSTRUMENT MANAGER (IM) TO THE LABORATORY INFORMATION SYSTEM (LIS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2254958 INSTRUMENT MANAGER SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP DATA INNOVATIONS LLC 8.17.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown