BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 ISE 1800 MODULE

    MDR report key: 22346082 · Received June 27, 2025

    Report

    Report Number
    1823260-2025-01973
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 30, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NA ELECTRODE LOT NUMBER IS DNR40. THE K ELECTRODE LOT NUMBER IS ECA41. THE CL ELECTRODE LOT NUMBER IS DRM90. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER FOUND AN ISSUE WITH THE VACUUM NOZZLE. HE REPLACED THE VACUUM NOZZLE AND THE SIPPER NOZZLE. THE CUSTOMER RAN QC WITH RESULTS WITHIN RANGE. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE, POTASSIUM ELECTRODE, AND ISE INDIRECT NA-K-CL FOR GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 ISE 1800 MODULE. PATIENT 1: THE INITIAL NA RESULT WAS 111 MMO/L, AND THE REPEATED RESULT WAS 138 MMOL/L. THE INITIAL K RESULT WAS 3.7 MMOL/L, AND THE REPEATED RESULT WAS 4.6 MMOL/L. THE INITIAL CL RESULT WAS 125 MMOL/L, AND THE REPEATED RESULT WAS 99 MMOL/L. THE SAMPLE WAS REPEATED BECAUSE THE INITIAL NA RESULT WAS MARKED AS A CRITICALLY LOW VALUE. PATIENT 2: ON (B)(6) 2025, THE INITIAL NA RESULT WAS 111 MMO/L, AND THE REPEATED RESULT WAS 132 MMO/L. ON (B)(6) 2025, THE INITIAL K RESULT WAS 3.4 MMO/L. AND THE REPEATED RESULT WAS 4.1 MMO/L. ON (B)(6) 2025, THE INITIAL CL RESULT WAS 129 MMO/L, AND THE REPEATED RESULT WAS 102 MMO/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813419 COBAS 8000 ISE 1800 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown