BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 801 ANALYTICAL UNIT

    MDR report key: 24674114 · Received March 24, 2026

    Report

    Report Number
    1823260-2026-01051
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    March 1, 2026
    Report Date
    March 24, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K162606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 882496 AND THE EXPIRATION DATE IS 31-JAN-2027. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T GEN 5 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 35.0 NG/L. THE DOCTOR QUESTIONED THE RESULT WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 12.4 NG/L. THE CUSTOMER ALSO REPEATED THE SAMPLE ON ANOTHER ANALYZER AND THE RESULT CONFIRMED THE REPEAT RESULT. THE EXACT RESULT WAS NOT PROVIDED. THE REPEAT RESULT WAS DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736937 COBAS E 801 ANALYTICAL UNIT IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown