BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (RACK SYSTEM)

    MDR report key: 21751078 · Received April 2, 2025

    Report

    Report Number
    1823260-2025-00975
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 10, 2025
    Report Date
    April 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924721
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO A PREANALYTIC ISSUE AT THE CUSTOMER SITE (CUSTOMER'S PATIENT SAMPLE DILUTION PROCESS). PREANALYTICS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 792358. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER¿S HARDWARE DURING THE DILUTION. HE PERFORMED MINOR ADJUSTMENTS FOR OPTIMUM PERFORMANCE. THE ANALYZER¿S PERFORMANCE WAS VERIFIED BY SUCCESSFUL QCS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ESTRADIOL III RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS E411 RACK. TWO PATIENT SAMPLES WITH DISCREPANT RESULTS WERE PROVIDED: PATIENT SAMPLE 1 THE INITIAL RESULT WAS GREATER THAN 11,010 PMOL/L WITH A DATA FLAG. THE REPEAT RESULT AT 1:10 ONBOARD DILUTION WAS 7448 PMOL/L. PATIENT SAMPLE 2 THE INITIAL RESULT WAS GREATER THAN 11,010 PMOL/L WITH A DATA FLAG. THE REPEAT RESULT AT 1:10 ONBOARD DILUTION WAS 9413 PMOL/L. THE REPORTER EXPECTED THE 1:10 DILUTION RESULTS TO BE HIGHER THAN 11,010 PMOL/L. THE REPORTER STATED THEY OBTAINED A MORE CLINICALLY APPROPRIATE RESULT AT 1:2 DILUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264044 COBAS E 411 ANALYZER (RACK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown