BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPUC3

    MDR report key: 15292741 · Received August 25, 2022

    Report

    Report Number
    1823260-2022-02540
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Date of Event
    July 25, 2022
    Report Date
    October 24, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGQ
    UDI-DI
    04015630919536
    PMA / PMN Number
    K141925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER PRODUCT LABELING, "URINE, CSF AND CONTROL SAMPLES WITH A PROTEIN CONCENTRATION ABOVE 7000 MG/L (700 MG/DL) MAY CLOG THE INSTRUMENT LINES." THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE PATIENT HAD VIRAL MENINGITIS AT THE TIME OF SAMPLE COLLECTION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE INFORMATION IN THE PREVIOUS SUPPLEMENTAL REPORT WAS INCORRECT. THE CORRECT INFORMATION IS: THE INVESTIGATION FOUND THAT THE ISSUE IS CONSISTENT WITH ELEVATED PROTEIN CONCENTRATION IN THE PATIENT'S SAMPLE. PER PRODUCT LABELING, "URINE, CSF AND CONTROL SAMPLES WITH A PROTEIN CONCENTRATION ABOVE 7000 MG/L (700 MG/DL) MAY CLOG THE INSTRUMENT LINES."

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE TPUC3 TOTAL PROTEIN CSF GEN.3 RESULTS ON A COBAS 4000 C311 ANALYZER WITH SERIAL NUMBER (B)(4). THE INITIAL CSF TP RESULT WAS 13.85 G/L. THE HIGH RESULT PROMPTED THE CUSTOMER TO SEND THE SAMPLE TO ANOTHER LAB TO REPEAT IT. THE REPEAT RESULT FROM THE OTHER LAB WITH THE SAME REAGENT LOT ON A C8000 ANALYZER WAS 14 G/L. THE SECOND LAB REFERRED THE SAMPLE TO A THIRD REFERENCE LAB FOR ELECTROPHORESIS AND PANDY SULFOSALICYLIC ACID QUALITATIVE TESTING AND THE RESULTS CAME BACK WITHIN NORMAL RANGE. THE ELECTROPHORESIS RESULT MATCHED THE PATIENT'S CLINICAL PICTURE. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE ELECTROPHORESIS RESULT WAS DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432843 TPUC3 TURBIDIMETRIC, TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS TPUC G3 59944801 04015630919536

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown