BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 10535492 · Received September 15, 2020

    Report

    Report Number
    1823260-2020-02261
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 21, 2020
    Report Date
    October 7, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGQ
    PMA / PMN Number
    K071239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER MAINTENANCE WAS FINE. QC DATA WAS ACCEPTABLE. THE TPUC3 RESULTS OF 0.140 G/L AND 12.851 G/L USING 1:10 DILUTION WERE NOT ACCOMPANIED BY DATA FLAGS. ALL OTHER TPUC3 RESULTS WERE ACCOMPANIED BY AN >ABS DATA FLAG. THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO A HIGH DOSE HOOK-EFFECT. PRODUCT LABELING STATES: "SAMPLE RESULTS WITH HIGH TOTAL PROTEIN CONCENTRATIONS ABOVE THE MEASURING RANGE UP TO 100000 MG/L (=100 G/L) WILL BE FLAGGED BY THE INSTRUMENT WITH >TEST OR >ABS." PRODUCT LABELING ALSO STATES: "URINE, CSF, AND CONTROL SAMPLES WITH A PROTEIN CONCENTRATION ABOVE 7000 MG/L (700 MG/DL) MAY CLOG THE INSTRUMENT LINES." DUE TO THE TEST PRINCIPLE, TURBIDIMETRIC (PRECIPITATION METHOD WITH BENZETHONIUM CHLORIDE), THE SAMPLE CONCENTRATION IS DETECTED AS FALSE LOW AND SOMETIMES FLAGGED WITH >ABS DUE TO THE PRECIPITATE FORMATION IN THE CUVETTE. THE >ABS DATA ALARM INDICATES THAT THE ABSORBANCE IS HIGHER THAN THE ABSORBANCE LIMIT, AND THE RESULT IS NOT VALID. THE CONCENTRATION IS FALSE LOW DUE TO THE PROTEIN FLOCCULATION IN THE CUVETTE SINCE THE PROTEIN CONCENTRATION WAS TOO HIGH, HIGHER THAN 7000 MG/L (7 G/L).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR TPUC3 TOTAL PROTEIN URINE/CSF GEN.3 (TPUC3) ON A COBAS 8000 C 502 MODULE. THE INITIAL RESULT WAS 0.461 G/L WITH A DATA FLAG. THE REPEAT RESULT IN DECREASED MODE (1:3) WAS 4.572 G/L WITH A DATA FLAG. THE SAMPLE WAS REPEATED A 3RD TIME USING 1:10 DILUTION AND THE RESULT WAS 0.140 G/L. THE SAMPLE WAS RE-ANALYZED 3 DAYS LATER AND THE RESULT WAS 0.493 G/L WITH A DATA FLAG. THE RESULT IN DECREASED MODE (1:3) WAS 4.786 G/L WITH A DATA FLAG. THE RESULT USING A 1:10 DILUTION WAS 12.851 G/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE C502 MODULE SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001825 TOTAL PROTEIN URINE/CSF GEN.3 TURBIDIMETRIC, TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS TPUC G3 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1