BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPUC3

    MDR report key: 18816883 · Received March 1, 2024

    Report

    Report Number
    1823260-2024-00614
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    January 5, 2024
    Report Date
    November 1, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGQ
    UDI-DI
    04015630919536
    PMA / PMN Number
    K141925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT SAMPLES WERE RECEIVED FOR INVESTIGATION. THE CUSTOMER'S RESULTS WERE ABLE TO BE CONFIRMED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH AN UNKNOWN HIGH-MOLECULAR SUBSTANCE IN THE PATIENT SAMPLES. PER PRODUCT LABELING, "IN VERY RARE CASES, GAMMOPATHY, IN PARTICULAR TYPE IGM (WALDENSTRÖM¿S MACROGLOBULINEMIA), MAY CAUSE UNRELIABLE RESULTS."

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6) . THE PATIENT SAMPLES WERE REQUESTED FOR INVESTIGATION. 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 4 PATIENT CEREBROSPINAL FLUID SAMPLES ON A COBAS 8000 COBAS C 502 MODULE. THE CUSTOMER ALLEGED THAT THE TOTAL PROTEIN RESULTS WERE NOT PLAUSIBLE AND DID NOT MATCH WITH OTHER RESULT FINDINGS AS THE TOTAL PROTEIN CONCENTRATION WAS LOWER THAN THE ALBUMIN MEASUREMENT. ON (B)(6) 2024, SAMPLE 1 HAD A TPUC3 RESULT OF 652.1 MG/L. THE ALBUMIN RESULT WAS 814 MG/DL. THE SAMPLE WAS ALSO TESTED ON A SIEMENS ADVIA ANALYZER. THE TOTAL PROTEIN RESULT WAS 1282 MG/L AND THE ALBUMIN RESULT WAS 814 MG/DL. ON (B)(6) 2024, SAMPLE 1 WAS TESTED AGAIN AND THE TPUC3 RESULT WAS 798 MG/L AND THE ALBUMIN RESULT WAS 921 MG/L. ON (B)(6) 2024, SAMPLE 2 HAD A TPUC3 RESULT OF 257.0 MG/L. THE ALBUMIN RESULT WAS 333.0 MG/DL. ON (B)(6) 2024, SAMPLE 3 HAD A TPUC3 RESULT OF 279.7 MG/L. THE ALBUMIN RESULT WAS 361.0 MG/DL. ON (B)(6) 2024, SAMPLE 4 HAD A TPUC3 RESULT OF 403.4 MG/L. THE ALBUMIN RESULT WAS 529.0 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305897 TPUC3 TURBIDIMETRIC, TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS 751584 04015630919536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown