BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 10607524 · Received September 30, 2020

    Report

    Report Number
    1823260-2020-02406
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 9, 2020
    Report Date
    December 22, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGQ
    PMA / PMN Number
    K071239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM AS NO SAMPLE MATERIAL WAS AVAILABLE FOR FURTHER TESTING. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INITIAL TESTING WAS PERFORMED ON AN UNACCEPTABLE SAMPLE TYPE OF A RANDOM URINE SAMPLE. PER PRODUCT LABELING "USE 24-HOUR URINE SPECIMENS. USE NO PRESERVATIVES. REFRIGERATE SPECIMEN DURING COLLECTION CENTRIFUGE SAMPLES CONTAINING PRECIPITATES BEFORE PERFORMING THE ASSAY."

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE TPUC3 TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FOR ONE PATIENT FROM THE COBAS 6000 C (501) MODULE SERIAL NUMBER (B)(4). THE CUSTOMER SUSPECTED AN INTERFERENCE. THE PATIENT'S TOTAL PROTEIN URINE RESULT WAS 100 MG/DL ON THREE OUT OF FOUR VISITS IN THE LAST 30 DAYS, THE LATEST BEING (B)(6) 2020. ON ALL THREE OF THESE VISITS, ANOTHER URINE SAMPLE FROM THE PATIENT WAS TESTED WITH A CLINITECH TESTING STRIP READ BY AN IRICELL 2000. THE RESULT WAS <15 MG/DL. ON ONE OF THE VISITS, THE TOTAL PROTEIN URINE RESULT WAS 200 MG/DL AND CLINITECH TESTING STRIP DETECTED <50 MG/DL. THE SPECIFIC DATE OF THIS EVENT WAS NOT KNOWN. THE CUSTOMER STATED THEY HAVE CONFIRMED THE NEGATIVE RESULTS FROM THE DIPSTICK WITH SERUM PROTEIN ELECTROPHORESIS. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072038 TOTAL PROTEIN URINE/CSF GEN.3 TURBIDIMETRIC, TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS TPUC G3 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR DICLOFENAC SODIUM.| FOLIC ACID.| LEBOTHYROXINE.| METHOCARBAMOL.| METHOTREXATE.| PREDNISONE.| DICLOFENAC SODIUM| FOLIC ACID| LEBOTHYROXINE| METHOCARBAMOL| METHOTREXATE| PREDNISONE