BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPUC3

    MDR report key: 18543071 · Received January 19, 2024

    Report

    Report Number
    1823260-2024-00179
    Event Type
    Malfunction
    Date Received
    January 19, 2024
    Date of Event
    December 25, 2023
    Report Date
    March 1, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGQ
    UDI-DI
    04015630925179
    PMA / PMN Number
    K071239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE ANALYZER WAS FUNCTIONING. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TPUC3 TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FOR 1 PATIENT URINE SAMPLE ON A COBAS 8000 COBAS C 701 MODULE. THE INITIAL URINE TPUC3 RESULT WAS 1.4 G/L. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLE AS THEY RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE REPEAT RESULT WAS 0.5 G/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247773 TPUC3 TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS 750333 04015630925179

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female