BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (DISK SYSTEM)

    MDR report key: 16213760 · Received January 20, 2023

    Report

    Report Number
    1823260-2023-00190
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    January 3, 2023
    Report Date
    February 22, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630937103
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER FOUND AN ISSUE WITH THE SAMPLE/REAGENT PROBE PINCH TUBING AND IT WAS REPLACED. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS E411 DISK ANALYZER. PATIENT 1 INITIAL ELECSYS TSH ASSAY RESULT WAS 0.018 MUI/L WITH A DATA FLAG AND THE REPEAT RESULT WAS 9.52 MUI/L WITH A DATA FLAG. PATIENT 2 INITIAL ELECSYS TSH ASSAY RESULT WAS 2.24 MUI/L AND THE REPEAT RESULTS WERE 0.020 MUI/L AND 0.018 MUI/L. PATIENT 3 INITIAL TOTAL PSA RESULT WAS 9.97 NG/ML WITH A DATA FLAG AND THE REPEAT RESULTS WERE 0.025 NG/ML AND 0.024 NG/ML. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT NUMBERS AND EXPIRATION DATE WERE REQUESTED BUT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364446 COBAS E 411 ANALYZER (DISK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 DISK NA 04015630937103

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown