BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPUC3

    MDR report key: 17030348 · Received May 31, 2023

    Report

    Report Number
    1823260-2023-01791
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    April 30, 2023
    Report Date
    May 31, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGQ
    UDI-DI
    04015630919536
    PMA / PMN Number
    K141925
    Removal / Correction Number
    NA
    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 CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION FOR THE INVESTIGATION. BASED ON THE INFORMATION PROVIDED, THE ISSUE IS CONSISTENT WITH A HIGH PROTEIN CONCENTRATION IN THE PATIENT¿S SAMPLE. PER PRODUCT LABELING: "URINE, CSF AND CONTROL SAMPLES WITH A PROTEIN CONCENTRATION ABOVE 7000 MG/L MUST NOT BE MEASURED WITH TPUC3 AS THIS MAY CLOG THE INSTRUMENT LINES.". THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE TPUC3 (TOTAL PROTEIN URINE/CSF GEN. 3) ASSAY ON A COBAS 6000 C 501 MODULE, SERIAL NUMBER (B)(6). THE SAMPLE INITIALLY RESULTED IN A TPUC3 VALUE OF 0.7 G/L. THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED, RESULTING IN A TPUC3 VALUE OF 14.8 G/L. THE REPORTER ALSO MENTIONED THAT URINE TEST STRIPS SHOW A HIGH PROTEIN CONCENTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681813 TPUC3 TURBIDIMETRIC, TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS TPUC G3 ASKU 04015630919536

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown