BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXLAB; APTIO AUTOMATION

    MDR report key: 8128634 · Received December 4, 2018

    Report

    Report Number
    3010825766-2018-00002
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Report Date
    December 4, 2018
    Manufacturer
    INPECO SA
    Product Code
    JQP
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INPECO HAS INVESTIGATED THE ISSUES. THE IMPACT ON PATIENTS DEPENDS ON THE DM CONFIGURED IN THE SPECIFIC LABORATORY. ISSUE (B)(4): IN THE DMS VERSIONS R18 AND R18.1, IN CASE ONE OF THE FIELDS, WHICH TRIGGER THE DM RULE, IS EMPTY AT THE RESOLUTION OF THE RULE, DMS RETURNS "0" INSTEAD OF THE VALUE "FALSE" TO FILL THE EMPTY FIELD. IN THIS SCENARIO, ONLY IN CASE THE DM RULE COMPARES NUMERIC VALUE (COMPARISON OPERATORS < AND <=) AND IN CASE OF TESTS WHERE 0 HAS A MEANING, THIS BEHAVIOR OF DMS COULD GET TO A WRONG INTERPRETATION OF THE CONDITION AND A CONSEQUENT WRONG APPLICATION OF THE ACTIONS OF THE RULE. NONE OF THE PREVIOUS DMS VERSIONS IS IMPACTED BY THE ISSUE SINCE IN THE DESCRIBED SITUATION DMS ALWAYS RETURNS THE VALUE "FALSE". ISSUE (B)(4): THE ONLY IMPACTED DM RULES ARE THE DM WITH THE FUNCTIONS "HASRESULT", "COUNTRE RUN" AND "GET AVERAGE RESULT" IN THE DMS VERSIONS R18 AND R18.1. IN THESE CASES, WHEN THE CONDITION OF DM RULE IS CONFIGURED WITH A PARAMETER (SET "PARAMETER FIELD"), THE FUNCTION DOES NOT WORK PROPERLY: "HAS RESULT" AND "COUNTRE RUN" RETURN ALWAYS FALSE, WHILE "GET AVERAGE RESULT" RETURNS A NOT CORRECT VALUE. THIS BEHAVIOR COULD GET A WRONG APPLICATION OF THE ACTIONS OF THE RULE. INPECO HAS VERIFIED THAT THEY CANNOT HAPPEN ON THE FIELD DUE TO THE SPECIFIC CONFIGURATION OF THE DM RULES AT THE CUSTOMER SITES USING DMS VERSIONS R18 AND R18.1. THE ISSUES COULD POTENTIALLY AFFECT PATIENTS IN CASE, IN THE SITES WITH DMS R18 AND R18.1, FSES CHANGE OR ADD DM RULES AS DESCRIBED ABOVE. THE ISSUES WERE FIXED IN DMS VERSION R18.1.1. INPECO HAS INFORMED THE FSES TO UPGRADE DMS VERSION TO R18.1.1: - IN ALL THE SITES WITH DMS R18 AND R18.1 IN THE EVENT THE CUSTOMER NEEDS TO CONFIGURE DM RULES; - IN ALL THE SITES WITH DMS VERSIONS PREVIOUS R18 WHERE THE CUSTOMER WANTS TO UPGRADE DMS SOFTWARE IN THE EVENT HE IS USING OR IS GOING TO USE DM RULES. NO FIELD SAFETY CORRECTIVE ACTION IS NEEDED SINCE NONE OF THE CUSTOMER IS IMPACTED AT PRESENT.

    Description of Event or Problem · 1

    TWO ISSUES WERE FOUND DURING IN-HOUSE TESTING BY INPECO R&D. THE ISSUES IMPACT THE DATA MANAGEMENT SYSTEM (DMS) OF FLEXLAB AND APTIO® AUTOMATION. BOTH BUGS INVOLVE THE DECISION MAKING (DM) WHICH IS A FUNCTIONALITY AVAILABLE ON DMS THAT ALLOWS TO CREATE RULES FOR THE MANAGEMENT OF THE TUBES/TESTS IN THE AUTOMATIC PROCESSING OF TEST RESULTS. IN BOTH CASES, THE ISSUES COULD LEAD TO A WRONG APPLICATION OF THE ACTIONS OF THE DM RULES POTENTIALLY CAUSING AN IMPACT ON PATIENT DUE TO DELAYED OR INCORRECT TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968809 FLEXLAB; APTIO AUTOMATION LABORATORY AUTOMATION SYSTEM JQP INPECO SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other