BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (DISK SYSTEM)

    MDR report key: 23267273 · Received October 10, 2025

    Report

    Report Number
    1823260-2025-04145
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 14, 2025
    Report Date
    November 6, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630937103
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PERTINENT FIELDS IN SECTION D, G1, AND G4 PMA / 510K (PREMARKET NUMBERS) UPDATED. THE CUSTOMER HAS IDENTIFIED THE CAUSE OF THE EVENT AS A PREANALYTIC ISSUE AT THEIR SITE. THE PATIENT SAMPLE TUBE WAS INCORRECTLY POSITIONED, WHICH LED TO INCORRECT PIPETTING OF THE SAMPLE. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    THE COBAS E 411 ANALYZER (DISK SYSTEM) SERIAL NUMBER IS (B)(6). THE FIELD SERVICE ENGINEER INSPECTED THE ANALYZER AND PERFORMED LIQUID FLOW CLEANING (LFC) FOR THE INTERNAL PATHWAYS OF THE SIPPER, SAMPLE, AND REAGENT (SR) PROBES. KEY COMPONENTS WERE REPLACED, INCLUDING THE SR AND SIPPER PROBE TUBING, AS WELL AS THE MEASURING CELL AND ITS CONNECTING TUBING. FOLLOWING THE HARDWARE INSTALLATION, SYSTEM SETTINGS WERE VERIFIED, AND MINOR ADJUSTMENTS WERE MADE TO THE SR PROBE POSITIONS. A FULL SYSTEM VERIFICATION WAS THEN CONDUCTED, WITH THE INSTRUMENT SUCCESSFULLY PASSING THE VOLUME, VOLTAGE, BLANK CELL, MECHANICAL CHECKS, AND CALIBRATIONS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TROPONIN T HS STAT AND ELECSYS PROBNP II RESULTS FROM A PATIENT SAMPLE TESTED ON THE COBAS E 411 ANALYZER (DISK SYSTEM). THIS MEDWATCH IS FOR THE ELECSYS PROBNP II ASSAY. THE INITIAL RESULT WAS 1731.0 PG/ML. THE REPEAT RESULT WAS <10.00 PG/ML. PLEASE REFER TO THE MEDWATCH WITH A.1 PATIENT IDENTIFIER PT-0080528 FOR THE ELECSYS TROPONIN T HS STAT ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112584 COBAS E 411 ANALYZER (DISK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E 411 84169203 04015630937103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown