BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INFINITY CORE SOFTWARE

    MDR report key: 10641044 · Received October 7, 2020

    Report

    Report Number
    1823260-2020-02468
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 9, 2020
    Report Date
    October 7, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE COBAS INFINITY SOFTWARE CAN BE CONFIGURED WITH DIFFERENT DATE FORMATS. THIS CAN BE SET IN THE GENERAL PARAMETER OF "DATE FORMAT." THE USER IS ABLE TO SELECT EITHER A 2-DIGIT YEAR FORMAT OR A 4-DIGIT YEAR FORMAT. THE SOFTWARE CAN CALCULATE THE PATIENT AGE BY THE DATE OF BIRTH ENTERED, AND THE DATE WHEN THE SAMPLE CORRESPONDING TO THE ORDER WAS COLLECTED. IF THE COLLECTION DATE IS NOT PROVIDED, THE SOFTWARE USES THE ORDER DATE. A DATE COMBO BOX, AS THE ONE USED FOR THE SAMPLE COLLECTION DATE DEMOGRAPHIC, IS A COMBINATION OF A TEXT FIELD AND A DROPDOWN. THE DROPDOWN DISPLAYS A DATE PICKER SO THAT WHEN A DATE IS SELECTED, IT IS CORRECTLY INTRODUCED IN THE DATE FIELD. HOWEVER, DURING THE INVESTIGATION, IT WAS FOUND THAT WHEN THE DATE IS MANUALLY TYPED INTO THE DATE FIELD, THE FOLLOWING SCENARIOS CAN OCCUR: IF THE TYPED DATE IS ENTERED USING A 4-DIGIT YEAR, THE CORRECT DATE IS SET. IF THE TYPED DATE IS ENTERED USING A 2-DIGIT YEAR (ONLY THE LAST 2 DIGITS OF THE YEAR ARE ENTERED), THE SOFTWARE ASSIGNS THE DATE TO THE 19XX YEARS (1900-1999). THEREFORE, IF THE USER TYPES "24/09/20", THE SYSTEM WILL ERRONEOUSLY ASSIGN THE DATE 24/09/1920. THE ISSUE HAPPENS FOR ALL THE DATE COMBO BOXES THAT APPEAR IN THE SOFTWARE, SUCH AS ORDER ENTRY DATE, SAMPLE COLLECTION DATE, PATIENT DATE OF BIRTH, ETC. IN THIS CASE, THE USER MANUALLY TYPED THE SAMPLE COLLECTION DATE INTO THE FIELD USING ONLY 2 DIGITS FOR THE YEAR. AS THE YEAR THAT WAS ENTERED WAS FROM THIS CENTURY, THE SOFTWARE ASSIGNED THE INCORRECT SAMPLE COLLECTION DATE. THEREFORE, THE CALCULATED PATIENT AGE FOR THAT ORDER WAS NOT CORRECT. SOME REFERENCE RANGES THAT CAN BE DEFINED IN THE SOFTWARE ARE DEPENDENT ON THE AGE. THEN, THE REFERENCE RANGES TO BE USED AND DISPLAYED BY THE SOFTWARE WILL NOT BE THE CORRECT ONES DUE TO AN ERRONEOUSLY CALCULATED PATIENT AGE. A WORKAROUND HAS BEEN PROVIDED (TYPE THE COMPLETE 4-DIGIT YEAR IN THE DATE COMBO BOX). THE INVESTIGATION CONFIRMED THIS AS A SOFTWARE ISSUE.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF A SOFTWARE ISSUE WITH COBAS INFINITY SOFTWARE VERSION (B)(4). THE CUSTOMER ALLEGED THE SOFTWARE WAS NOT CALCULATING PATIENT AGES CORRECTLY, WHICH COULD AFFECT THE INTERPRETATION OF REFERENCE RANGES FOR TESTS THAT ARE DEPENDENT ON THE AGE OF A PATIENT. NO PATIENTS WERE HARMED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105696 COBAS INFINITY CORE SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1