BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPUC3

    MDR report key: 18685456 · Received February 12, 2024

    Report

    Report Number
    1823260-2024-00395
    Event Type
    Malfunction
    Date Received
    February 12, 2024
    Date of Event
    January 16, 2024
    Report Date
    April 12, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGQ
    UDI-DI
    04015630925179
    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 COBAS 8000 C702 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    D4 EXPIRATION DATE WAS UPDATED. A GENERAL REAGENT ISSUE WAS EXCLUDED SINCE CALIBRATION AND QC DATA WERE ACCEPTABLE. AN INTERFERENCE WAS UNLIKELY BECAUSE THE REACTION MONITOR FOR THE DISCREPANT RESULT WAS INCONSPICUOUS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN (TPUC3) RESULTS FOR ONE PATIENT FROM THE COBAS 8000 C702 MODULE COMPARED TO ANOTHER C702 MODULE. THE INITIAL RESULTS WERE 50.0 MG/DL AND 51.43 MG/DL. THE REPEAT RESULTS ON ANOTHER C702 MODULE WERE 33.0 MG/DL AND 33.9 MG/DL. THE REPEAT RESULTS FROM ANOTHER C702 MODULE IN ANOTHER LABORATORY WERE 48 MG/DL AND 49 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396456 TPUC3 TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS 750333 04015630925179

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male FEBURIC TAB| FOICHOL TAB| GODEX CAP| KAROS SUSPENSION| LACIDOFIL CAP| LASIX TAB| POLYBUTINE SR TAB| URSA TAB