BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHIUM

    MDR report key: 23008386 · Received September 9, 2025

    Report

    Report Number
    1823260-2025-02799
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 18, 2025
    Report Date
    September 9, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NDW
    PMA / PMN Number
    K063684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE LITHIUM RESULTS FOR 1 PATIENT ON A COBAS 6000 C501 MODULE. 2 SAMPLES FROM THE SAME PATIENT WERE TESTED. SAMPLE 1: THE INITIAL RESULT WAS 4.31 MMOL/L WITH A DATA FLAG, AND THE REPEATED RESULT WITH A DILUTION WAS 1.05 MMOL/L. SAMPLE 2: THE INITIAL RESULT WAS 2.92 MMOL/L WITH A DATA FLAG, AND THE REPEATED RESULT WAS 1.05 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049127 LITHIUM LITHIUM TEST SYSTEM NDW ROCHE DIAGNOSTICS 811780

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown