BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INFINITY LAB CORE LICENSE 3.X

    MDR report key: 19642971 · Received July 1, 2024

    Report

    Report Number
    1823260-2024-01892
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 5, 2024
    Report Date
    August 6, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JQP
    UDI-DI
    07613336177129
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    DURING INVESTIGATIONS, THE CUSTOMER'S ALLEGATION COULD BE REPRODUCED. IN ORDER FOR THE ISSUE TO OCCUR, THERE MUST BE A MINIMUM NUMBER OF QC BRACKETS IN THE DATABASE (200+). WHEN THIS HAPPENS THE BAD QC MIGHT NOT CLOSE THE OPEN BRACKET, THEREFORE THE NEXT OK QC IS TAKEN AS A NEW QC OPENING AND RELEASING ALL THE PATIENT RESULTS BETWEEN THE LAST GOOD QC AND CURRENT GOOD QC. THE INVESTIGATION DETERMINED THERE IS A SOFTWARE ISSUE IN COBAS INFINITY AS THE QUERY USED FOR RETRIEVING THE QC BRACKETS DOES NOT TAKE INTO ACCOUNT A DOCUMENTED DATABASE LIMITATION WHEN USING THE "ORDER BY" AND "GROUP BY" CLAUSES.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY HAD AN ISSUE WITH THE COBAS INFINITY SOFTWARE. WITH THE SOFTWARE VERSION 3.05.05, THE CUSTOMER ENCOUNTERED AN ISSUE WITH QC BRACKETING. WHEN THE COBAS INFINITY SOFTWARE RECEIVES PATIENT RESULTS THAT WERE MEASURED BETWEEN A GOOD QC AND A BAD QC, THE COBAS INFINITY SOFTWARE WILL REMOVE QC BRACKETING (QCB) FLAGS FROM THE RESULTS ONCE GOOD QC IS OBTAINED. THIS OCCURS WITH BOTH INITIAL AND REPEAT PATIENT RESULTS. THE COBAS INFINITY SOFTWARE IS EXPECTED TO NOT REMOVE THE QC BRACKETING FLAGS FROM RESULTS IN THIS SCENARIO. WHEN PATIENT RESULTS ARE FLAGGED WITH QCB, THE RELEASE OF THESE RESULTS TO THE CUSTOMER'S LABORATORY INFORMATION SYSTEM IS PREVENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2183940 COBAS INFINITY LAB CORE LICENSE 3.X CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE JQP ROCHE DIAGNOSTICS 07613336177129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown