BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 21583558 · Received March 12, 2025

    Report

    Report Number
    1823260-2025-00715
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    February 19, 2025
    Report Date
    April 2, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIQ
    UDI-DI
    04015630919536
    PMA / PMN Number
    K141925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELDS D4 LOT NO AND D4 EXPIRATION DATE WERE UPDATED. BASED ON THE FREQUENT OCCURRENCE OF SAMPLE-RELATED ALARMS, THE INVESTIGATION DETERMINED THAT THE EVENT WAS CONSISTENT WITH PREANALYTIC ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS THE CUSTOMER'S RESPONSIBILITY. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    THE COBAS 8000 COBAS C 502 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 0.02 G/L AND THE REPEAT RESULT WAS 1.06 G/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958787 TOTAL PROTEIN URINE/CSF GEN.3 TURBIDIMETRIC, TOTAL PROTEIN JIQ ROCHE DIAGNOSTICS 837924 04015630919536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown