BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (RACK SYSTEM)

    MDR report key: 25027217 · Received April 29, 2026

    Report

    Report Number
    1823260-2026-01685
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 18, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924721
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TESTOSTERONE REAGENT LOT NUMBER WAS 851750. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. CALIBRATION AND CONTROLS WERE ACCEPTABLE. IT WAS OBSERVED THAT THE MIXER WAS CAUSING FOAM FORMATION. THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER, INCLUDING CHECKING THE MIXER, PROBE ADJUSTMENTS, PROBE TUBING, LIQUID LEVEL DETECTION VOLTAGE, GROUNDING, AND WATER CONDUCTIVITY. THE UNINTERRUPTIBLE POWER SUPPLY UNIT HAD A PLUG THAT WAS REVERSED, WHICH CAUSED THE POTENTIAL DIFFERENCE BETWEEN NEUTRAL AND GROUND TO BE > 10 VOLTS. THE PLUG WAS CORRECTED. GROUNDING AND LIQUID LEVEL DETECTION VOLTAGE WERE RE-CHECKED. PERFORMANCE TESTING WAS RUN AND WITHIN SPECIFICATIONS. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH INSUFFICIENT MAINTENANCE. IT WAS DETERMINED THAT ADJUSTMENTS TO THE MIXER AND SAMPLE PROBE LIQUID LEVEL DETECTION WERE NEEDED. THE ISSUE WAS RESOLVED AFTER PERFORMANCE OF THE SERVICE ACTIONS.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TESTOSTERONE II ASSAY ON A COBAS E 411 ANALYZER. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT VALUE WAS DEEMED CORRECT. THE SAMPLE INITIALLY RESULTED IN A TESTOSTERONE VALUE OF 8.97 NG/ML. THE SAMPLE WAS REPEATED ON (B)(6) 2026, RESULTING IN A VALUE OF 4.29 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618283 COBAS E 411 ANALYZER (RACK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E 411 04015630924721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown