BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONLINE TDM AMIKACIN

    MDR report key: 25174387 · Received May 14, 2026

    Report

    Report Number
    1823260-2026-01910
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 19, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KLP
    UDI-DI
    07613336133514
    PMA / PMN Number
    K032279
    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 C 703 ANALYZER SERIAL NUMBER IS (B)(6). THE COBAS 8000 ANALYZER SERIAL NUMBER WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ONLINE TDM AMIKACIN RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 703 ANALYTICAL UNIT AND A COBAS 8000 ANALYZER. THE INITIAL RESULT FROM THE C 703 ANALYZER WAS 1.02 UG/ML WITH A FLAG. THE SAMPLE WAS REPEATED ON THE COBAS 8000 AND THE RESULT WAS 2.15 UG/ML WITH A FLAG. THE SAMPLE WAS REPEATED ON THE C 703 ANALYZER AND THE RESULT WAS <0.8 UG/ML WITH A FLAG. THE SAMPLE WAS REPEATED TWO MORE TIMES ON THE COBAS 8000 ANALYZER AND THE RESULTS WERE 2.05 UG/ML WITH FLAG AND 2.11 UG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566041 ONLINE TDM AMIKACIN AMIKACIN SERUM ASSAY KLP ROCHE DIAGNOSTICS 921017 07613336133514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown