BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 ISE 1800 MODULE

    MDR report key: 21942768 · Received May 1, 2025

    Report

    Report Number
    1823260-2025-01357
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 1, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SODIUM ELECTRODE LOT NUMBER WAS DBT WITH AN EXPIRATION DATE OF 28-DEC-2025. THE CHLORIDE ELECTRODE LOT NUMBER WAS BCB WITH AN EXPIRATION DATE OF 12-AUG-2025. THE FIELD SERVICE ENGINEER FOUND THE SIPPER NOZZLE WAS CLOGGED AND REPLACED THE SIPPER NOZZLE. HE RAN ISE CHECKS, CALIBRATION, AND QC. ALL RESULTS MET SPECIFICATIONS. OPERATIONAL AND/OR MECHANICAL CHECKS PASSED. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF ANALYZER ALARMS AND QUESTIONABLE RESULTS FOR APPROXIMATELY 19 PATIENTS FROM THE COBAS 8000 COBAS ISE MODULE (DOUBLE) ANALYZER. DATA WAS PROVIDED FOR ONE PATIENT. THE INITIAL SODIUM RESULT WAS 126 MMOL/L, AND THE REPEAT RESULT WAS 143 MMOL/L. THE INITIAL CHLORIDE RESULT WAS 93 MMOL/L, AND THE REPEAT RESULT WAS 104 MMOL/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655727 COBAS 8000 ISE 1800 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female