BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPUC3

    MDR report key: 20106130 · Received August 30, 2024

    Report

    Report Number
    1823260-2024-02512
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    August 7, 2024
    Report Date
    February 24, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGQ
    PMA / PMN Number
    K071239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TPUC3 REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE C702 MODULE SERIAL NUMBER WAS (B)(6). THE CUSTOMER USES A 3RD PARTY QC. QC WAS WITHIN THE ASSIGNED RANGES ON THE DAY OF THE EVENT. THE ALARM TRACE SHOWED MULTIPLE ABNORMAL ASPIRATION (SAMPLE PROBE) ALARMS, A SAMPLE CLOT ALARM, AND A COUPLE OF SAMPLE SHORT ALARMS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THERE WAS FLUCTUATION AT THE BEGINNING OF THE CALIBRATION TRACE BUT THEN IT BECAME STABLE WITHIN SPECIFICATIONS. THE REACTION KINETICS SHOWED A VERY STRONG ABNORMAL COURSE. SUCH CURVES ARE USUALLY TRIGGERED BY GAMMOPATHY. GAMMOPATHY IS INCREASINGLY OBSERVED IN PATIENTS DIAGNOSED WITH CANCER, WHICH WAS SUPPORTED IN THIS EVENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS CONSISTENT WITH A SAMPLE-RELATED (E.G. GAMMOPATHY) AND A PREANALYTIC ISSUE AT THE CUSTOMER SITE. PREANALYTICS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT URINE SAMPLE TESTED WITH TOTAL PROTEIN URINE/CSF GEN.3 (TPUC3) ASSAY ON A COBAS 8000 C702 MODULE. RANDOM RESULT: 21.7 MG/DL. 24 HOURS RESULT: 0.0 MG/DAY. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE RESULT OF 21.7 MG/DL WAS REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912248 TPUC3 TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS 767916

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male