BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 ISE 1800 MODULE

    MDR report key: 22565540 · Received July 22, 2025

    Report

    Report Number
    1823260-2025-02234
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 22, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NA ELECTRODE LOT NUMBER IS DKN, AND THE EXPIRATION DATE IS 15-FEB-2026. THE QC WAS NOT ACCEPTABLE. THE ALARM TRACE SHOWED "ABNORMAL ASPIRATION (SAMPLE PROBE)" AND "SAMPLE SHORT" ERRORS. THE FIELD SERVICE REPRESENTATIVE FOUND THAT THE INTERNAL STANDARD TUBING WAS PINCHED. HE REPLACED THE TUBING, PERFORMED PRIMES, AIR PURGES, AND CHECKS AND TESTS WITH ACCEPTABLE RESULTS. 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 SODIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 ISE 1800 MODULE. THE INITIAL RESULT WAS 132 MMOL/L. THE REPEATED RESULT WAS 145 MMOL/L. THE REPEATED RESULT WAS OBTAINED ON ANOTHER MODULE AND WAS BELIEVED TO BE CORRECT. A NEGATIVE ANION GAP RESULT PROMPTED THE SAMPLE TO BE REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766881 COBAS 8000 ISE 1800 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male