BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPUC3

    MDR report key: 19524283 · Received June 12, 2024

    Report

    Report Number
    1823260-2024-01749
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 23, 2024
    Report Date
    August 21, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGQ
    UDI-DI
    04015630919536
    PMA / PMN Number
    K141925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE COBAS 8000 COBAS C 502 MODULE IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELDS A. PATIENT INFORMATION, B7 OTHER RELEVANT HISTORY, AND D10 CONCOMITANT MEDICAL PRODUCTS UPDATED. THE CUSTOMER REPORTED THE TPUC3 RESULT OF 216 MG/DL. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE TPUC3 TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FROM ONE URINE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 502 MODULE. THE REPORTER WAS NOT ABLE TO PROVIDE THE DATE THE EVENT OCCURRED. THE DATE THE EVENT WAS REPORTED WAS USED AS THE DATE OF EVENT. THE PATIENT SAMPLE WAS RUN IN UNIT 1 AND UNIT 2 OF THE MODULE. THE INITIAL RESULT OF THE UNDILUTED PATIENT SAMPLE FROM UNIT 1 WAS 248 MG/DL. THE REPEAT RESULT WITH THE PATIENT SAMPLE AT AN UNKNOWN DILUTION FROM UNIT 1 WAS 132 MG/DL. THE INITIAL RESULT OF THE UNDILUTED PATIENT SAMPLE FROM UNIT 2 WAS 247 MG/DL. THE REPEAT RESULT WITH THE PATIENT SAMPLE AT AN UNKNOWN DILUTION FROM UNIT 2 WAS 141 MG/DL. THE REPORTER PERFORMED A DILUTION SERIES FOR RESULT CONFIRMATION. THE UNIT OF THE MODULE USED WAS NOT PROVIDED. THE REPEAT RESULT OF THE UNDILUTED SAMPLE WAS 259 MG/DL. THE REPEAT RESULT WITH THE PATIENT SAMPLE AT A 2-FOLD DILUTION WAS 108 MG/DL WITH A FINAL DILUTION RESULT OF 216 MG/DL. THE REPEAT RESULT WITH THE PATIENT SAMPLE AT A 4-FOLD DILUTION WAS 46 MG/DL WITH A FINAL DILUTION RESULT OF 184 MG/DL. THE REPEAT RESULT WITH THE PATIENT SAMPLE AT AN 8-FOLD DILUTION WAS 18 MG/DL WITH A FINAL DILUTION RESULT OF 144 MG/DL. THE REPORTER DEEMED THE RESULTS OF THE UNDILUTED PATIENT SAMPLES WERE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157580 TPUC3 TURBIDIMETRIC, TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS ASKU 04015630919536

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female DEXAMETHASONE| FEBUXOSTAT| NALDEMEDINE TOSILATE| OXYCODONE