BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 12746163 · Received November 3, 2021

    Report

    Report Number
    1823260-2021-03205
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 8, 2021
    Report Date
    December 16, 2021
    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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION RESULTS AND THE CUSTOMER RESULTS ARE COMPARABLE AND WITHIN THE EXPECTED RANGE. A REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION FOUND THE OBSERVED DIFFERENCES ARE CONSISTENT WITH THE UNDERLYING DIFFERENCES IN TEST PRINCIPLES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER STATED THEY HAD PROVIDED THE INCORRECT UNITS OF MEASUREMENT AS "MG/L" INITIALLY. THE CORRECT UNITS OF MEASUREMENT ARE MG/DL. PLEASE REFER TO THE ATTACHED DATA FOR UPDATED CUSTOMER RESULTS. THE PATIENT'S COMPLAINED SAMPLE WAS INVESTIGATED BY THE MANUFACTURER. PLEASE REFER TO THE ATTACHED DATA.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THERE WAS A COMPLAINT OF QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FOR 1 PATIENT TESTED WITH TWO COBAS 8000 C502 MODULES. THE COBAS 8000 C502 MODULE SERIAL NUMBERS WERE (B)(4). THE SAMPLE TYPE WAS URINE. THE PATIENT¿S INITIAL RESULT ON MODULE A WAS 100 MG/L; THE REPEAT WAS 100 MG/L. THE PATIENT¿S INITIAL RESULT ON MODULE B WAS 100 MG/L; THE REPEAT WAS 100 MG/L. THE PATIENT¿S SAMPLE WAS TESTED ON AN UNSPECIFIED COMPETITOR'S ANALYZER VIA A QUALITATIVE TEST AND RECEIVED A NEGATIVE RESULT. THE PATIENT¿S SAMPLE WAS TESTED WITH A PYROGALLOL RED METHOD AND RECEIVED A RESULT OF 7 MG/L. IT IS UNKNOWN IF THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1642239 TOTAL PROTEIN URINE/CSF GEN.3 TURBIDIMETRIC, TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS TPUC G3 ASKU 04015630919536

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown