BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 23256138 · Received October 9, 2025

    Report

    Report Number
    1823260-2025-04125
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 16, 2025
    Report Date
    December 19, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIQ
    PMA / PMN Number
    K141925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALARM TRACE SHOWED "ABNORMAL PROBE SUCKING" ALARMS. A PRE-ANALYTICAL HANDLING ISSUE COULD NOT BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A SPECIFIC CAUSE OF THE EVENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE COBAS 6000 C501 MODULE SERIAL NUMBER (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FROM ONE URINE PATIENT SAMPLE TESTED ON THE COBAS 6000 C501 MODULE. THE INITIAL RESULT FROM THE MODULE WAS 68 MG/DL. THE REPEAT RESULT WAS 55 MG/DL. THE REPEAT RESULT FROM A DIMENSION EXL200 (SIEMENS, FLEX CARTRIDGE URINE CEREBROSPINAL FLUID PROTEIN UCFP/PYROGALLOL RED LABORATORY METHOD) WAS 19 MG/DL. THE URINE QUALITATIVE RESULT WAS NEGATIVE. THE REPORTER STATED THAT THE PATIENT IS MEDICATED WITH PLAQUENIL (ACTIVE INGREDIENT: HYDROXYCHLOROQUINE SULFATE) AND WOULD LIKE TO KNOW IF THIS DRUG INTERFERES WITH THE ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582813 TOTAL PROTEIN URINE/CSF GEN.3 TURBIDIMETRIC, TOTAL PROTEIN JIQ ROCHE DIAGNOSTICS 86777201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PLAQUENIL (WITH HYDROXYCHLOROQUINE SULFATE).