BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INFINITY CORE SOFTWARE

    MDR report key: 8992478 · Received September 11, 2019

    Report

    Report Number
    1823260-2019-03268
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 21, 2019
    Report Date
    October 8, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REPRODUCED AND CONFIRMED THE ISSUE IN THE REPORTED SOFTWARE VERSION (3.00.00) AND IN THE LATEST AVAILABLE VERSION OF THE SOFTWARE (3.01.02). THE AFFECTED SOFTWARE VERSIONS 3.00.00 OR HIGHER WERE NOT LAUNCHED IN THE UNITED STATES. BASED ON THIS INFORMATION, THIS EVENT COULD NOT OCCUR IN THE UNITED STATES, THEREFORE, THERE IS NO RISK TO USERS IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN ABLE TO REPRODUCE THE CUSTOMER'S ALLEGATION. THE INVESTIGATION IS CURRENTLY ONGOING. THE EVENT OCCURRED IN: (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THAT THERE IS A PROBLEM WITH THE COBAS INFINITY SOFTWARE (VERSION 3.00.00) THAT COULD AFFECT THE INTERPRETATION OF PATIENT RESULTS. WHEN CHANGING A TEST RULE FOR ONE APPLICATION IN THE COBAS INFINITY SOFTWARE, THE RULES FOR OTHER TESTS WERE BEING INAPPROPRIATELY CHANGED. FOR EXAMPLE, THE CUSTOMER CHANGED THE INSTRUMENTS THAT WERE ASSIGNED TO THE RULE "RERUN W DEC." WITHIN 1 SECOND THE RULES FOR THE FT3 TESTS WERE CHANGED FROM "65-FT3-VRIJE T3" TO "152-LH-2-LH STAAL 2." THE FT3 RULES SHOULD NOT HAVE BEEN CHANGED. THIS COULD AFFECT HOW PATIENT RESULTS ARE HANDLED BY THE INFINITY SOFTWARE AND HOW THEY ARE INTERPRETED BY THE USER. THERE HAVE BEEN NO ALLEGATIONS OF ANY PATIENT RESULTS BEING AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792946 COBAS INFINITY CORE SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1