BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPUC3

    MDR report key: 19192430 · Received April 26, 2024

    Report

    Report Number
    1823260-2024-01289
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    March 25, 2024
    Report Date
    June 25, 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 6000 C501 MODULE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE HIGH TPUC3 TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FROM ONE URINE PATIENT SAMPLE TESTED ON THE COBAS 6000 C501 MODULE. THE INITIAL TPUC3 RESULT OF THE UNDILUTED PATIENT SAMPLE FROM THE MODULE WAS 152.6 MG/DL. THE REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:3 DILUTION FROM THE MODULE WAS 1193.4 MG/DL. THE REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE FROM THE MODULE WAS 132.6 MG/DL. THE REPEAT RESULT USING AN IMMUNOTURBIDIMETRY LABORATORY METHOD WAS 15.6 MG/L. THE REPORTER SENT THE PATIENT SAMPLE TO AN OUTSOURCED LABORATORY. THE REPEAT RESULT FROM A COMPETITOR ANALYZER USING AN IMMUNOTURBIDITY LABORATORY METHOD WAS 5.5 MG/L. THE PATIENT SAMPLE WAS ALSO SENT TO THE INVESTIGATION LABORATORY. THE REPEAT RESULT USING A BENZONTIUM CHLORIDE METHOD WAS 155.2 MG/DL. THE INVESTIGATION LABORATORY SUSPECTS THE PRESENCE OF AN INTERFERENT IN THE PATIENT SAMPLE. ADDITIONAL TPUC3 RESULTS OF 22.4 MG/DL AND 397.8 MG/DL WERE PROVIDED. IT IS NOT CLEAR HOW THESE RESULTS RELATE TO THE EVENT. CLARIFICATION HAS BEEN REQUESTED RELATED TO THESE RESULTS BUT HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122375 TPUC3 TURBIDIMETRIC, TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS 75158401 04015630919536

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male