BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPUC3

    MDR report key: 17612963 · Received August 24, 2023

    Report

    Report Number
    1823260-2023-02756
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    July 21, 2023
    Report Date
    September 29, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGQ
    UDI-DI
    04015630919536
    PMA / PMN Number
    K141925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    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 502 MODULE. THE INITIAL TPUC3 RESULT WAS 2.34 G/L. A URINE DIPSTICK TEST WAS PERFORMED AND IT SHOWED A VERY LOW PROTEIN CONCENTRATION. A WEEK LATER, THE SAMPLE WAS REPEATED AND THE TPUC3 RESULT WAS 1.73 G/L. A 1:2 DILUTION WAS PERFORMED AND THE RESULT WAS 0.75 G/L. THE SAMPLE WAS REPEATED AGAIN AND THE RESULT WAS 0.50 G/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070542 TPUC3 TURBIDIMETRIC, TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS 73011101 04015630919536

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown