BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 20050611 · Received August 23, 2024

    Report

    Report Number
    1225673-2024-00005
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 25, 2024
    Report Date
    August 23, 2024
    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

    THROUGH A COLLABORATIVE INVESTIGATION WITH THE USER FACILITY AND THE DISTRIBUTOR IT WAS DETERMINED THAT A RULE (USER FACILITY PROGRAMMED LOGIC) WAS DESIGNED TO CALCULATE MICROALBUMIN-TO-CREATININE RATIO (MCR). THIS RULE FIRED ON A STRING (>200) RESULT THAT LEFT THE CALCULATION OF MCR TO BE SET TO 0. PRIOR TO THE RULE BEING MOVED LIVE THE USER FACILITY DID NOT TEST AND VALIDATE THAT THE RULE WORKED AS INTENDED FOR ALL RESULTING SCENARIOS. ON (B)(6) 2024 A PATIENT MICROALBUMIN RESULT OF >200 WAS RECEIVED FROM THE ASSOCIATED INSTRUMENTATION AS PART OF A RERUN WORKFLOW. AS THE MICROALBUMIN RESULT WAS PASSED TO INSTRUMENT MANAGER AS ">200" AND THE RULE WAS NOT DESIGNED FOR EVALUATING THE RESULT FOR WHETHER IT WAS A NUMBER OR A STRING, THE RULE EXECUTED AND MODIFIED THE RESULT FROM >200 TO 0. THROUGH INVESTIGATION IT WAS DETERMINED THAT THE RULE (USER FACILITY PROGRAMMED LOGIC) WAS MISSING PARENTHESIS AROUND A PORTION OF THE RULE AND EVALUATION OF RESULT BEING A NUMBER PRIOR TO RUNNING A CALCULATION. FOR EXAMPLE, THE RULE SHOULD HAVE INCLUDED A NUMERIC CHECK WRITTEN AS (ISNUMERIC) BUT THE RULE HAD NOT BEEN DESIGNED TO NOT FIRE IF THE RESULT CONTAINED <.> OR HAD A RESULT OF EXCEPTION. THIS RESULTED IN THE MCR BEING CALCULATED USING A MICROALBUMIN RESULT OF >200 AND THE RESULTANT MCR BEING REPORTED AS "0". THE DISTRIBUTOR AND USER FACILITY MODIFIED THE RULE TO APPLY THE ADDITIONAL CONDITIONS BEFORE FIRING. ADDITIONALLY, THE RULE NO LONGER MANIPULATES THE RESULT DIRECTLY AND INSTEAD SETS THE RESULT TO "SEE COMMENT" FOR FURTHER SCRUTINY OF RESULT AUTHENTICITY. WHILE THIS IS NOT A MALFUNCTION OF THE INSTRUMENT MANAGER MEDICAL DEVICE (RULES WERE WORKING AS EXPECTED) IT IS BEING REPORTED DUE TO THE FACILITIES INABILITY TO PROVIDE A PATIENT IMPACT OF THE USER ERROR.

    Description of Event or Problem · 0

    MICROALBUMIN CREATININE RATIO WAS CALCULATED AS 0. RESULT WAS SENT TO THE PATIENT CHART. URINE MICROALBUMIN HAD AN INITIAL RESULT OF >50, MEDICAL TECHNOLOGIST PERFORMED A DILUTION AND THE RERUN RESULT WAS >200.0. THIS CAUSE THE MICROALBUMIN CREATININE RATIO CALCULATION RULT TO FIRE, DESPITE NOT HAVING A NUMERIC RESULT FOR URINE MICROALBUMIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380871 INSTRUMENT MANAGER SOFTWARE INSTRUMENT MANAGER SOFTWARE JQP DATA INNOVATIONS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown