BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (DISK SYSTEM)

    MDR report key: 21700977 · Received March 26, 2025

    Report

    Report Number
    1823260-2025-00895
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    February 21, 2025
    Report Date
    April 25, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630937103
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 802253. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND AN ISSUE WITH THE MEASURING CELL CARRYOVER. HE PERFORMED MAINTENANCE AND REPLACED AN OVERDUE MEASURING CELL, SIPPER PROBE, AND PINCH VALVE TUBING. HE NOTED THAT THE INSTRUMENT WAS VERY DIRTY. HE THOROUGHLY CLEANED THE INSTRUMENT. HE PERFORMED ADJUSTMENTS, CHECKS, AND TESTS WITH ACCEPTABLE RESULTS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CALIBRATION DATA INDICATED SIGNALS FOR ONE CALIBRATOR LEVEL THAT WERE HIGHER THAN EXPECTED. THE QC WAS ACCEPTABLE. A GENERAL REAGENT ISSUE WAS EXCLUDED. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T GEN 5 STAT RESULTS FOR 3 PATIENT SAMPLES ON A COBAS E 411 ANALYZER (DISK SYSTEM). PATIENT (B)(6): THE INITIAL RESULT WAS 78 NG/L, AND THE REPEATED RESULT WAS <6.00 NG/L. PATIENT (B)(6): ON (B)(6) 2025, THE INITIAL RESULT WAS 77 NG/L, AND THE REPEATED RESULT WAS <6.00 NG/L. PATIENT (B)(6): ON (B)(6) 2025, THE INITIAL RESULT WAS 50.27 NG/L, AND THE REPEATED RESULT WAS <6.00 NG/L. THE SAMPLES WERE REPEATED BECAUSE THE INITIAL RESULTS WERE QUESTIONED BY THE PHYSICIAN. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER MODULE AND WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785956 COBAS E 411 ANALYZER (DISK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630937103

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female