BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 20537489 · Received October 25, 2024

    Report

    Report Number
    1225673-2024-00007
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    September 27, 2024
    Report Date
    October 25, 2024
    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 LLC (MANUFACTURER), THE DISTRIBUTOR, AND THE USER FACILITY. INVESTIGATION DETERMINED AN AHCV RULE (USER FACILITY PROGRAMMED LOGIC) FOR A HEPATITIS C VIRUS TEST FIRED AND SET THE PATIENT RESULTS TO BE "REACTIVE" CORRECTLY ACCORDING TO THE RULE SET FOR THE RESULTS GREATER THAN 1. AN HCV "REACTIVE" TEST RESULT SHOULD HAVE BEEN HELD FOR COMPLETION OF REFLEX TESTING BEFORE BEING POSTED TO THE PATIENT CHART. INVESTIGATION ALSO DETERMINED THAT AN AHCV RULE TO HOLD RESULTS PENDING REFLEX TESTING WAS NOT IN PLACE. THIS IS NOT A MALFUNCTION OF INSTRUMENT MANAGER MEDICAL DEVICE. TO ADDRESS THE ISSUE, THE DISTRIBUTOR AND USER FACILITY ADDED A SPECIMEN INTEGRITY RULE FOR HEPATITIS INTERPRETATIONS TO ENSURE THAT FUTURE RESULTS WILL BE HELD AS EXPECTED. THE USER FACILITY INDICATED THAT THE "REACTIVE" RESULTS WERE SENT TO 4 PATIENT CHARTS. ALL CLINICIANS WERE NOTIFIED OF THE NEED FOR ALL 4 PATIENTS TO RETURN TO THE FACILITY TO HAVE ANOTHER SPECIMEN DRAWN SO THAT REFLEX TESTING COULD BE PERFORMED. A PATIENT IMPACT STATEMENT HAS NOT YET BEEN RECEIVED BY DATA INNOVATIONS AND THEREFORE PATIENT IMPACT HAS BEEN UNABLE TO BE DETERMINED AT THIS TIME. AN INVESTIGATION TO DETERMINE POTENTIAL PATIENT IMPACT IS ONGOING AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    A REPRESENTATIVE FROM THE RESELLER REPORTED ON (B)(6) 2024 THAT A RESULT OF "REACTIVE" FOR A HEP C TEST WAS REPORTED TO THE PATIENT CHART WHEN IT SHOULD NOT HAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819056 INSTRUMENT MANAGER SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE, PRODUCT CODE JQP DATA INNOVATIONS LLC 8.17.31

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown