BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 ISE 900 MODULE

    MDR report key: 21314054 · Received February 5, 2025

    Report

    Report Number
    1823260-2025-00345
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    January 21, 2025
    Report Date
    February 5, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECTRODE LOT NUMBERS AND THEIR EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED. ON THE FIELD SERVICE ENGINEER'S (FSE) INITIAL SERVICE VISIT, HE INSPECTED THE MODULE AND OBTAINED AN ABNORMAL ION-SELECTIVE ELECTRODE (ISE) CHECK. HE VERIFIED THE FUNCTIONS OF THE PIPELINE AND SIPPER NEEDLE. HE PREVENTIVELY REPLACED THE SYRINGE SEAL RING AND THE RELATED SOLENOID VALVE OF THE REFERENCE PIPELINE, DEGASSER, AND REFERENCE LIQUID-RELATED PIPES. THE REPEAT ISE CHECK WAS ACCEPTABLE. CALIBRATIONS, QC, AND REPEATABILITY TESTS WERE PERFORMED WITH ACCEPTABLE RESULTS. ON THE FSE'S FOLLOW-UP SERVICE VISIT, HE REPLACED THE SOLENOID VALVES, THE DEGASSER TANK, THE SYRINGE MAINTENANCE KIT, AND THE TUBING FOR THE REFERENCE LINE. THE CUSTOMER DID NOT REPORT ANY OTHER ISSUES AFTER SERVICE. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE NA, K, AND CL ELECTRODE RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS ISE MODULE. THE INITIAL NA RESULT WAS 160 MMOL/L. THE REPEAT RESULT WAS 142 MMOL/L. THE INITIAL K RESULT WAS 5.12 MMOL/L. THE REPEAT RESULT WAS 4.5 MMOL/L. THE INITIAL CL RESULT WAS 91 MMOL/L. THE REPEAT RESULT WAS 106 MMOL/L. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AS THEY DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54166 COBAS 8000 ISE 900 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown