BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS PRO ISE ANALYTICAL UNIT

    MDR report key: 24312642 · Received February 11, 2026

    Report

    Report Number
    1823260-2026-00466
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    January 19, 2026
    Report Date
    March 26, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SODIUM ELECTRODE LOT NUMBER WAS FEQ WITH AN EXPIRATION DATE OF 26-SEP-2026. THE POTASSIUM ELECTRODE LOT NUMBER WAS EYR WITH AN EXPIRATION DATE OF 30-AUG-2026. THE ISE INDIRECT NA-K-CL FOR GEN.2 (CHLORIDE) LOT NUMBER WAS FBY WITH AN EXPIRATION DATE OF 14-JUL-2026. THE QC WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE SIPPER NOZZLE WAS PARTIALLY CLOGGED. HE CLEANED THE DILUTION VESSEL AND FLUSHED THE SOLENOID VALVE ISE FLOW PATH. ISE CHECKS, CALIBRATION, AND QC WERE PERFORMED, AND THEY WERE WITHIN SPECIFICATIONS. THE FSE THEN VERIFIED THAT THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CALIBRATION FROM THE DATE OF THE EVENT WAS PROVIDED, AND IT WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE CAUSE OF THE EVENT WAS DUE TO A PARTIALLY CLOGGED SIPPER NOZZLE. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE SERVICE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE, POTASSIUM ELECTRODE, AND ION-SELECTIVE ELECTRODE (ISE) INDIRECT NA-K-CL FOR GEN.2 (CHLORIDE) RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS PRO ISE ANALYTICAL UNIT. SODIUM: INITIAL RESULT: 169 MMOL/L. REPEAT RESULT: 138 MMOL/L. POTASSIUM: INITIAL RESULT: 4.8 MMOL/L. REPEAT RESULT: 3.9 MMOL/L. CHLORIDE: INITIAL RESULT: 122 MMOL/L. REPEAT RESULT: 98 MMOL/L. THE INITIAL RESULTS DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS, PROMPTING THE REPEAT OF THE SAMPLE IN A DIFFERENT COBAS PRO ISE ANALYTICAL UNIT. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377984 COBAS PRO ISE ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown