BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (RACK SYSTEM)

    MDR report key: 24637010 · Received March 19, 2026

    Report

    Report Number
    1823260-2026-00994
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 27, 2026
    Report Date
    April 28, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924721
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE E411 ANALYZER SERIAL NUMBER WAS (B)(6).

    Additional Manufacturer Narrative · 0

    SECTION D, DEVICE IDENTIFICATION, WAS UPDATED. RELEVANT FIELDS OF SECTIONS D AND G WERE UPDATED. THE TOTAL PSA REAGENT LOT NUMBER WAS 840050 WITH AN EXPIRATION DATE OF 30-APR-2026. CALIBRATION FOR TOTAL PSA WAS LAST PERFORMED ON 20-NOV-2024. THE OPERATOR DERIVED THE DATA ON 05-MAR-2025. THE QC DATA WAS DERIVED ON 05-MAR-2025. THE DATE OF THE EVENT WAS 27-FEB-2026. IT WAS CONFIRMED THAT THE CUSTOMER MANIPULATED THE TIME AND DATE ON THE DISPLAY, WHICH LED TO THE DATE DISPLAYING BACK TO ONE YEAR AGO. THIS MANIPULATION OF TIME AND DATE IS CONSIDERED AN OFF-LABEL USE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED THAT THE ELECSYS FREE PSA (FREE PSA) WAS GREATER THAN THE ELECSYS TOTAL PSA (TOTAL PSA) FOR 1 PATIENT SAMPLE TESTED ON A COBAS E 411 ANALYZER (RACK SYSTEM). THIS MEDWATCH WILL COVER TOTAL PSA. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FREE PSA RESULTS. THE FREE PSA RESULT WAS 0.010 NG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 0.010 NG/ML. THE TOTAL PSA RESULT WAS 0.006 NG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 0.006 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228401 COBAS E 411 ANALYZER (RACK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E 411 840050 04015630924721

    Patients

    Seq Age Sex Outcome Treatment
    1