BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPUC3

    MDR report key: 20009474 · Received August 21, 2024

    Report

    Report Number
    1823260-2024-02388
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 19, 2024
    Report Date
    December 13, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGQ
    UDI-DI
    04015630925179
    PMA / PMN Number
    K071239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER STATED THERE WAS NO EVIDENCE OF GAMMOPATHY IN THE PATIENT. THE CUSTOMER STATED THAT THE 1:3 DILUTION WAS PERFORMED AS AN AUTOMATIC REPEAT BY THE ANALYZER. THE CUSTOMER STATED THAT DILUTIONS WERE PERFORMED TWICE MANUALLY BY DIFFERENT OPERATORS AND THE RESULTS WERE COMPARABLE. MEDWATCH FIELD D10 HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE C702 ANALYZER IS (B)(6). THE REACTION DATA FROM THE ANALYZER WAS CHECKED AND FOR THE INITIAL VALUE, IT APPEARS THAT A HIGH DOSE HOOK EFFECT IS LIKELY. THE INITIAL REPEAT, 1:3, AND 1:5 DILUTION REACTIONS APPEARED UNSTABLE. THE 1:2 DILUTION VALUE HAD DECREASING ABSORBANCE AT THE END OF THE REACTION. CALIBRATION AND CONTROLS WERE ACCEPTABLE, SO A GENERAL REAGENT ISSUE CAN BE RULED OUT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT URINE SAMPLE TESTED WITH TOTAL PROTEIN URINE/CSF GEN. 3 ON A COBAS 8000 C702 MODULE. THE SAMPLE INITIALLY RESULTED IN A TOTAL PROTEIN VALUE OF 3064 MG/L ACCOMPANIED BY A DATA FLAG INDICATING HIGH ABSORBANCE. THE SAMPLE WAS AUTOMATICALLY REPEATED, RESULTING IN A VALUE OF 1152 MG/L. THE SAMPLE WAS DILUTED 1:2 AND REPEATED, RESULTING IN A RAW TOTAL PROTEIN VALUE OF 1591 MG/L WHICH WAS CALCULATED TO A FINAL VALUE OF 3182 MG/L. THE SAMPLE WAS DILUTED 1:3 AND REPEATED, RESULTING IN A RAW TOTAL PROTEIN VALUE OF 931 MG/L WHICH WAS CALCULATED TO A FINAL VALUE OF 2793 MG/L. THE SAMPLE WAS DILUTED 1:5 AND REPEATED, RESULTING IN A RAW TOTAL PROTEIN VALUE OF 415 MG/L WHICH WAS CALCULATED TO A FINAL VALUE OF 2075 MG/L. THE SAMPLE WAS DILUTED 1:10 AND REPEATED, RESULTING IN A RAW TOTAL PROTEIN VALUE OF 104 MG/L WHICH WAS CALCULATED TO A FINAL VALUE OF 1040 MG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153327 TPUC3 TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS 79939500 04015630925179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CONTRACEPTIVE PILL CERAZETTE| CORTISONE| DAPAROX| ESOMEPRAZOL| FREMANEZUMAB| INFLIXIMAB| PAROXETIN| TRIPTAN