BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 8703368 · Received June 17, 2019

    Report

    Report Number
    1823260-2019-02197
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 24, 2019
    Report Date
    June 17, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGQ
    PMA / PMN Number
    K071239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED THE INVESTIGATION COULD NOT IDENTIFY A REAGENT OR INSTRUMENT PROBLEM. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE EVENT OCCURRED IN: (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF A QUESTIONABLE TPUC3 TOTAL PROTEIN URINE/CSF GEN.3 RESULT FOR A PATIENT'S URINE SAMPLE TESTED ON A COBAS 8000 C 502 MODULE COMPARED TO THE WAKO PYROGALLOL RED METHOD. THE RESULTS IN QUESTION WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499200 TOTAL PROTEIN URINE/CSF GEN.3 TURBIDIMETRIC, TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS TPUC G3 362863

    Patients

    Seq Age Sex Outcome Treatment
    1