BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (RACK SYSTEM)

    MDR report key: 24753443 · Received April 1, 2026

    Report

    Report Number
    1823260-2026-01200
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 1, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924721
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TSH REAGENT LOT NUMBER WAS 891754. THE FT4 REAGENT LOT NUMBER WAS 883869. THE TSH AND THE FT4 REAGENTS' EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) FOUND AN ISSUE WITH THE SAMPLE PROBE TUBING. HE REPLACED THE PINCH VALVE TUBINGS, THE SAMPLE PROBE TUBINGS, AND PRIMED THE SAMPLE/REAGENT PROBE. HE ALSO PRIMED THE SIPPER, ADJUSTED THE SAMPLE PROBE LIQUID LEVEL DETECTION VOLTAGE, AND PERFORMED MAINTENANCE ON THE INSTRUMENT. QC WAS PERFORMED, AND IT WAS WITHIN SPECIFICATIONS. THE FSE VERIFIED THAT THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT. THE CAUSE OF THE EVENT WAS DUE TO A COMPONENT FAILURE (AN ISSUE WITH THE SAMPLE PROBE TUBING).

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS TSH ASSAY AND ELECSYS FT4 G4 ASSAY ON A COBAS E 411 ANALYZER (RACK SYSTEM). TSH: INITIAL RESULT: "NO VALUE" WAS GENERATED AND (ACCOMPANIED BY A "<SIGNAL" DATA FLAG). 1ST REPEAT RESULT: 0.005 UIU/ML (ACCOMPANIED BY A DATA FLAG). 2ND REPEAT RESULT: "NO VALUE" WAS GENERATED AND (ACCOMPANIED BY A "<SIGNAL" DATA FLAG). 3RD REPEAT RESULT: "NO VALUE" WAS GENERATED AND (ACCOMPANIED BY A "<SIGNAL" DATA FLAG). 4TH REPEAT RESULT: 0.005 UIU/ML (ACCOMPANIED BY A DATA FLAG). 5TH REPEAT RESULT: "NO VALUE" WAS GENERATED AND (ACCOMPANIED BY A "<SIGNAL" DATA FLAG). 6TH REPEAT RESULT: 1.6 UIU/ML (TESTED IN A DIFFERENT LABORATORY). FT4: INITIAL RESULT: "NO VALUE" WAS GENERATED AND (ACCOMPANIED BY A "<SIGNAL" DATA FLAG). 1ST REPEAT RESULT: "NO VALUE" WAS GENERATED AND (ACCOMPANIED BY A "<SIGNAL" DATA FLAG). 2ND REPEAT RESULT: "NO VALUE" WAS GENERATED AND (ACCOMPANIED BY A "<SIGNAL" DATA FLAG). 3RD REPEAT RESULT: "NO VALUE" WAS GENERATED AND (ACCOMPANIED BY A "<SIGNAL" DATA FLAG). 4TH REPEAT RESULT: 16 PMOL/L (TESTED IN A DIFFERENT LABORATORY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18730 COBAS E 411 ANALYZER (RACK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E 411 04015630924721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown