BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INFINITY CORE SOFTWARE

    MDR report key: 8261388 · Received January 18, 2019

    Report

    Report Number
    1823260-2019-00236
    Event Type
    Malfunction
    Date Received
    January 18, 2019
    Date of Event
    January 4, 2019
    Report Date
    January 18, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF AN ISSUE WITH HOW THE COBAS INFINITY CORE LICENSE SOFTWARE VERSION 1.2.44 DISPLAYS PATIENT RESULTS FROM THE SKANNEX INSTRUMENT WHEN MORE THAN ONE TEST IS PERFORMED. WHEN THE SKANNEX INSTRUMENT SENDS THE RESULTS TO THE INFINITY SOFTWARE, THE RESULTS ARE SAVED CORRECTLY; HOWEVER, A REPEAT RESULT THAT HAS NOT BEEN PERFORMED IS DISPLAYED. NO ADVERSE EVENT HAS OCCURRED DUE TO THE ISSUE. THE INVESTIGATION WAS ABLE TO REPRODUCE THE ISSUE IN THE SOFTWARE VERSION COMPLAINED ABOUT AND VERSION 2.5.0. THE SKANNEX INSTRUMENT RECEIVES RESULTS THROUGH AN ".XML" FILE THAT IS LOCATED IN A PATH SPECIFIED THROUGH THE CONFIGURATION OF THE DRIVER. IN THIS CASE, THE MESSAGE CONTAINED RESULTS FOR 2 TESTS: "POSITIVE" FOR BENZODIAZEPINE (BZO) AND "NEGATIVE" FOR AMPHETAMINE (AMP). WHEN THIS FILE IS READ BY THE INFINITY SOFTWARE, THE RESULT FOR THE FIRST TEST (BZO) IS CORRECTLY DISPLAYED AS "POSITIVE" BUT THE RESULT FOR THE 2ND TEST (AMP) IS DISPLAYED INCORRECTLY. AN INITIAL "POSITIVE" RESULT IS ASSIGNED TO THE AMP TEST WITH A REPEAT "NEGATIVE" RESULT. THE INVESTIGATION FOUND THAT THIS BEHAVIOR ALWAYS OCCURS IF RESULTS FOR MORE THAN ONE TEST ARE SENT FROM THE SKANNEX INSTRUMENT TO THE INFINITY SOFTWARE. THE SOFTWARE PROCESSES THE FIRST RESULT CORRECTLY BUT THEN IT INITIALLY ASSIGNS THE RESULT FROM THE FIRST TEST TO THE 2ND TEST AND THEN UPDATES THE 2ND TEST WITH THE ACTUAL, CORRECT RESULT. NO WORKAROUND HAS BEEN IDENTIFIED FOR THIS ISSUE. THIS ISSUE HAS BEEN CONFIRMED AS A SOFTWARE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55134 COBAS INFINITY CORE SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1