BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® PULSE

    MDR report key: 23556200 · Received November 14, 2025

    Report

    Report Number
    1823260-2025-04645
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    October 6, 2025
    Report Date
    January 9, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PZI
    PMA / PMN Number
    K220272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IDENTIFIED A SOFTWARE ERROR-HANDLING ISSUE AS THE PRIMARY CAUSE OF THE REPORTED EVENT. THIS ERROR LED TO SYSTEM INSTABILITY AND A RESTART, FOLLOWED BY A FAILURE TO RETRIEVE A CRITICAL DATABASE KEY FROM THE NON-VOLATILE MEMORY. THE RESULTING DATABASE RE-INITIALIZATION CAUSED A LOSS OF DEVICE CONFIGURATION AND THE DELETION OF THE INTERNAL DATABASE BEFORE THE PATIENT DATA COULD BE TRANSMITTED. THE INVESTIGATION ALSO NOTED THAT ENVIRONMENTAL FACTORS, SPECIFICALLY POOR WIRELESS LOCAL AREA NETWORK (WLAN) CONNECTIVITY AND AUTHENTICATION FAILURES, WERE SIGNIFICANT CONTRIBUTING FACTORS TO THE SYSTEM INSTABILITY.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION THAT THE COBAS® PULSE WOULD RESET TO ITS DEFAULT SETTINGS, CAUSING IRREVERSIBLE PATIENT DATA LOSS. THE REPORTER STATED THAT THE RESULT FOR ONE PATIENT SAMPLE WAS NOT TRANSMITTED TO THE MIDDLEWARE AND TRACED THE CAUSE TO THE COBAS® PULSE REVERTING TO ITS DEFAULT SETTINGS, WHICH DELETED THE INTERNAL DATABASE. THERE WAS NO REPORT OF ANY HARM OR HEALTH CONSEQUENCES TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2851123 COBAS® PULSE PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING PZI ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown