BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 24915651 · Received April 17, 2026

    Report

    Report Number
    1823260-2026-01489
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 17, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIQ
    UDI-DI
    04015630919536
    PMA / PMN Number
    K141925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TOTAL PROTEIN URINE/CSF GEN.3 REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS 6000 C501 MODULE SERIAL NUMBER WAS (B)(6). THE SAMPLE WAS CLEAR AND NON-DISCOLORED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH TOTAL PROTEIN URINE/CSF GEN.3 ASSAY ON A COBAS 6000 C501 MODULE. INITIAL RESULT: 1028.3 MG/L (ACCOMPANIED BY A DATA FLAG). 1ST REPEAT RESULT: 5031.8 MG/L (AUTOMATICALLY DILUTED USING A DILUTION FACTOR OF 1:3). 2ND REPEAT RESULT: 1092.2 MG/L (ACCOMPANIED BY A DATA FLAG). ON (B)(6) 2026: 3RD REPEAT RESULT: 1175.3 MG/L. 4TH REPEAT RESULT: 4942.2 MG/L. ON (B)(6) 2026: 5TH REPEAT RESULT: 2148.1 MG/L (ACCOMPANIED BY A DATA FLAG). 6TH REPEAT RESULT: 2030.8 MG/L 7TH REPEAT RESULT: 663.0 MG/L (DILUTED USING A DILUTION FACTOR OF 1:3). ANOTHER SAMPLE WAS TESTED AT A DIFFERENT HOSPITAL USING AN UNKNOWN METHOD, RESULTING IN A TOTAL PROTEIN VALUE OF APPROXIMATELY 1000. THE UNIT OF MEASUREMENT WAS NOT PROVIDED. THE HIGH RESULT WAS QUESTIONED AS IT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY FOR TOTAL PROTEIN (VALUES AROUND 1000 MG/L).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970411 TOTAL PROTEIN URINE/CSF GEN.3 TURBIDIMETRIC, TOTAL PROTEIN JIQ ROCHE DIAGNOSTICS ASKU 04015630919536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown