BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPUC3

    MDR report key: 17375977 · Received July 24, 2023

    Report

    Report Number
    1823260-2023-02405
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    June 26, 2023
    Report Date
    August 29, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGQ
    UDI-DI
    07613336121535
    PMA / PMN Number
    K071239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REACTION MONITOR DATA SHOWED ABNORMALITIES. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION FOR THE INVESTIGATION. BASED ON A REVIEW OF WORLDWIDE DATA OF QC RECOVERY, A GENERAL REAGENT ISSUE WAS EXCLUDED. BASED ON THE LIMITED INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER OBSERVED THAT THE SAMPLE PROBE WAS DIRTY AND HAS TO BE CLEANED EVERY DAY SINCE THE LAST SERVICE VISIT. QC DATA SHOWED SOME IMPRECISION. ONE "ABNORMAL ASPIRATION" ALARM WAS OBSERVED IN THE ALARM TRACE DATA. THE INVESTIGATION IS ONGOING. H3 OTHER TEXT : NA.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE URINE PATIENT SAMPLE TESTED WITH TPUC3 (TOTAL PROTEIN URINE/CSF GEN.3) ON A COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(6). ON (B)(6) 2023, THE SAMPLE INITIALLY RESULTED IN A TPUC3 VALUE OF 1.40 G/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. ON (B)(6) 2023, THE SAMPLE WAS REPEATED RESULTING IN A TPUC3 VALUE OF 0.0835 G/L. THIS RESULT IS CONSISTENT WITH THE VERY LOW CONCENTRATION RESULTS OBTAINED WITH THE URINE STRIP TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233848 TPUC3 TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS NA 69928301 07613336121535

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown