BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHIUM

    MDR report key: 23350214 · Received October 21, 2025

    Report

    Report Number
    1823260-2025-04279
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    October 1, 2025
    Report Date
    November 10, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NDW
    UDI-DI
    07613336121382
    PMA / PMN Number
    K063684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE C703 SYSTEM IS NOT CLEARED OR APPROVED FOR USE IN THE UNITED STATES AND IS NOT SIMILAR TO A DEVICE CLEARED OR APPROVED IN THE UNITED STATES. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE C703 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH LITHIUM ON A COBAS C 703 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A LITHIUM VALUE OF 2.43 NMOL/L AND IT REPEATED AS 0.94 NMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817398 LITHIUM LITHIUM ASSAY NDW ROCHE DIAGNOSTICS ASKU 07613336121382

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown