BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER

    MDR report key: 20216901 · Received September 13, 2024

    Report

    Report Number
    1225673-2024-00006
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 13, 2024
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION WITH THE USER FACILITY, IT WAS DETERMINED THAT RULES (USER PROGRAMMED LOGIC) WERE NOT FUNCTIONING AS INTENDED DUE TO THE PROGRAMMING OF THOSE RULES. FOR EXAMPLE, THE RULES SHOULD HAVE INCLUDED CRITERIA TO HOLD, AND SAID CRITERIA WAS NOT WRITTEN INTO THE RULE. DATA INNOVATIONS LLC IDENTIFIED THE USER FACILITY HAD PROGRAMMED THE RULES INCORRECTLY SUCH THAT THE RULES WERE MISSING THE CRITERIA TO HOLD THE RESULTS. ONCE THE RESULT OF THE ERROR WAS LOCATED, DATA INNOVATIONS ASSISTED THE USER FACILITY IN CORRECTING RULE TO HOLD RESULTS AS INTENDED. WHILE THIS IS NOT A MALFUNCTION OF THE INSTRUMENT MANAGER MEDICAL DEVICE IT IS BEING REPORTED DUE TO THE FACILITIES INABILITY TO PROVIDE A STATEMENT OF PATIENT IMPACT DUE TO THE USER ERROR.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED ON (B)(6)2024 TWO RULES IMPLEMENTED TO HOLD TEST RESULTS WITH RESULTS BELOW THE ANALYTICAL MEASURE RANGE (AMR) WERE NOT WORKING AS INTENDED. RESULTS WHICH WERE BELOW THE AMR WERE BEING RELEASED AND NOT HELD AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114118 INSTRUMENT MANAGER CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP DATA INNOVATIONS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown