BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 602 MODULE

    MDR report key: 22185484 · Received June 11, 2025

    Report

    Report Number
    1823260-2025-01797
    Event Type
    Malfunction
    Date Received
    June 11, 2025
    Date of Event
    May 7, 2025
    Report Date
    June 27, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630929764
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE QC WAS ACCEPTABLE. THE FIELD SERVICE REPRESENTATIVE FOUND THE INSTRUMENT WAS OVERDUE FOR PREVENTATIVE MAINTENANCE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    AS THE INSTRUMENT WAS BEING DEINSTALLED, FURTHER INVESTIGATION WAS NOT POSSIBLE. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TROPON T HS STAT RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 602 MODULE. PATIENT 1: THE INITIAL RESULT WAS 120.1 NG/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE (COBAS E411), AND THE RESULT WAS 9 NG/L. THIS RESULT MATCHED THE PATIENT'S CLINICAL PICTURE. THE SAMPLE WAS REPEATED ON THE SAME MODULE AS THE INITIAL RESULT, AND THE RESULT WAS 21.91 NG/L REPORTED AS 22 NG/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE (COBAS PRO), AND THE RESULTS WERE 3 NG/L, 3 NG/L, 3.23 NG/L, 3 NG/L, AND 3 NG/L. ON (B)(6) 2025, THE SAMPLE WAS REPEATED ON THE SAME MODULE AS THE INITIAL RESULT, AND THE RESULTS WERE 10.96 NG/L, 4.29 NG/L, 9.14 NG/L, AND 4.45 NG/L. PATIENT 2: THE INITIAL RESULT WAS 78.97 NG/L REPORTED AS 49 NG/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE (COBAS E411), AND THE RESULT WAS 20 NG/L. THIS RESULT MATCHED THE PATIENT'S CLINICAL PICTURE. THE SAMPLE WAS REPEATED ON THE SAME MODULE AS THE INITIAL RESULT, AND THE RESULT WAS 30 NG/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE (COBAS PRO), AND THE RESULTS WERE 15.4 NG/L, 15.3 NG/L, 15.1 NG/L, 15.6 NG/L, AND 15.3 NG/L. ON (B)(6) 2025, THE SAMPLE WAS REPEATED ON THE SAME MODULE AS THE INITIAL RESULT, AND THE RESULTS WERE 14.24 NG/L, 14.24 NG/L, AND 14.52 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69839 COBAS E 602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630929764

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown