BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 801 ANALYTICAL UNIT

    MDR report key: 25176538 · Received May 14, 2026

    Report

    Report Number
    1823260-2026-01911
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    March 30, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K162606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECSYS TROPONIN T HS REAGENT LOT NUMBER IS 88252001 (EXPIRATION DATE: 31-JAN-2027).

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TROPONIN T HS RESULTS FOR 8 PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. PATIENT SAMPLE 1 ON (B)(6) 2026: THE INITIAL RESULT WAS 33.3 NG/L. THE FIRST REPEAT RESULT WAS 27.8 NG/L. THE SECOND REPEAT RESULT WAS 27.3 NG/L. PATIENT SAMPLE 2 ON (B)(6) 2026: THE INITIAL RESULT WAS 9.75 NG/L. THE FIRST REPEAT RESULT WAS 5.12 NG/L. THE SECOND REPEAT RESULT WAS 4.74 NG/L. PATIENT SAMPLE 3 ON (B)(6) 2026: THE INITIAL RESULT WAS 8.90 NG/L. THE REPEAT RESULT WAS 5.26 NG/L. PATIENT SAMPLE 4 ON (B)(6) 2026: THE INITIAL RESULT WAS 29.4 NG/L. THE FIRST REPEAT RESULT WAS 25.9 NG/L. THE SECOND REPEAT RESULT WAS 22.0 NG/L. PATIENT SAMPLE 5 ON (B)(6) 2026: THE INITIAL RESULT WAS 41.9 NG/L. THE FIRST REPEAT RESULT WAS 12.0 NG/L. THE SECOND REPEAT RESULT WAS 7.89 NG/L. PATIENT SAMPLE 6 ON (B)(6) 2026: THE INITIAL RESULT WAS 12.9 NG/L. THE REPEAT RESULT WAS 9.79 NG/L. PATIENT SAMPLE 7 ON (B)(6) 2026: THE INITIAL RESULT WAS 6.38 NG/L. THE FIRST REPEAT RESULT WAS 3.00 NG/L. PATIENT SAMPLE 8 ON (B)(6) 2026: THE INITIAL RESULT WAS 17.5 NG/L. THE FIRST REPEAT RESULT WAS 13.0 NG/L. THE SECOND REPEAT RESULT WAS 11.9 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627558 COBAS E 801 ANALYTICAL UNIT IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801

    Patients

    Seq Age Sex Outcome Treatment
    1