BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® 6800 SYSTEM

    MDR report key: 23244919 · Received October 8, 2025

    Report

    Report Number
    1823260-2025-04099
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 5, 2025
    Report Date
    December 1, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    MZA
    UDI-DI
    04015630935406
    PMA / PMN Number
    BK140196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELDS D1, D2, D4, G1, AND G4 WERE UPDATED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE ALLEGED BEHAVIOR COULD NOT BE REPRODUCED IN A TEST ENVIRONMENT. THE INVESTIGATION DETERMINED THAT NO SOFTWARE ISSUE WAS FOUND WITH THE NAVIFY LAB OPERATIONS (NLO) AS IT BEHAVED AS CONFIGURED AND DESIGNED FOR THE RECEIVED MESSAGES WITH THE U04 ALARM AND SUBSEQUENT SENDING OF RESULTS TO THE EXTERNAL HOST WITH DISABLED FLAGS. THE OBSERVED BEHAVIOR WAS A RESULT OF THE COMBINED COBAS 6800 INSTRUMENT AND NLO CONFIGURATION. HOWEVER, THE EXACT REASON THE CUSTOMER'S SYSTEM SENT THE MESSAGES REMAINS UNCLEAR. A RULE IN NLO WAS IMPLEMENTED AT THE CUSTOMER SITE THAT CHECKS ALL RESULTS FOR FLAG U04 AND IF IT OCCURS, A REPEAT RUN WILL BE PERFORMED. THUS, INVALID RESULTS WITH FLAG U04 WON¿T BE RELEASED TO THE CUSTOMER'S LABORATORY INFORMATION SYSTEM (LIS), AND PREVENT THE ISSUE FROM RECURRING AGAIN.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED THAT THE COBAS INFINITY TRANSMITTED INCORRECT PATIENT RESULTS TO THE LABORATORY INFORMATION SYSTEM (LIS). THE ISSUE OCCURED DUE TO AN ABORTED 6800 RUN AS THE SYSTEM COULD NO LONGER DISPOSE OF CLOTTED TIPS DUE TO FULL CLOTTED TIP RACKS. THEREFORE, THE SAMPLES ON THE RUN WERE INVALIDATED WITH 35 OUL^R22 MESSAGES INCLUDING THE U04 FLAG. HOWEVER, THE COBAS INFINITY PROCESSED THE MESSAGES/FLAG AS RESULTS AND 35 PATIENT SAMPLE RESULTS WERE AUTOMATICALLY REPORTED AS "NEGATIVE" IN THE LIS. NOTE, OUT OF THE 35 AFFECTED SAMPLES, 29 WERE LATER RETESTED SUCCESSFULLY AND RECEIVED VALID NEGATIVE RESULTS. FURTHER DETAILS FOR THE SIX SAMPLES WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2583131 COBAS® 6800 SYSTEM TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN MZA ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG 04015630935406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown