BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 24303864 · Received February 10, 2026

    Report

    Report Number
    1823260-2026-00451
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    December 16, 2025
    Report Date
    April 17, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELD H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSION WERE UPDATED. AN INVESTIGATION OF THE SAMPLE IDENTIFIED MONOCLONAL IGM-KAPPA IN THE PATIENT'S SERUM THAT INTERACTED ABNORMALLY WITH THE ASSAY REAGENTS, A KNOWN PHENOMENON IN PATIENTS WITH PLASMA CELL DYSCRASIAS. PER PRODUCT LABELING, "AS WITH OTHER TURBIDIMETRIC OR NEPHELOMETRIC PROCEDURES, THIS TEST MAY NOT PROVIDE ACCURATE RESULTS IN PATIENTS WITH MONOCLONAL GAMMOPATHY, DUE TO INDIVIDUAL SAMPLE CHARACTERISTICS WHICH CAN BE ASSESSED BY ELECTROPHORESIS." THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE WAS A PATIENT-SPECIFIC BIOLOGICAL INTERFERENCE.

    Additional Manufacturer Narrative · 0

    THE TINA-QUANT IGM GEN.2 REAGENT LOT NUMBER IS 802899, AND THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT IGM GEN.2 RESULT FROM THE COBAS C 503 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 368 MG/DL, WITH A REPEAT RESULT OF 364 MG/DL. THE SAMPLE WAS MEASURED AT ANOTHER LABORATORY ON (B)(6) 2025, USING ANOTHER C 503 ANALYZER WITH A RESULT OF 723 MG/DL. AT THE OTHER LABORATATORY THEY ALSO MEASURED THE SAMPLE ON A MASS SPECTROMETRY ANALYZER, MALDI-TOF, AND FOUND MONOCLONAL IGM-KAPPA AS A MASS-SHIFTED LIGHT CHAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350048 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown