BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS PRO ISE ANALYTICAL UNIT

    MDR report key: 25116336 · Received May 7, 2026

    Report

    Report Number
    1823260-2026-01793
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 7, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECTRODE LOT NUMBER IS GBC WITH AN EXPIRATION DATE OF 16-JAN-2027. THE CALIBRATION WAS ACCEPTABLE. THE QC DATA SHOW AN OUTLIER ON THE DAY OF THE EVENT. THE ALARM TRACE SHOWED "ABNORMAL ASPIRATION (SAMPLE PROBE)" ALARMS. THE FIELD SERVICE REPRESENTATIVE ADJUSTED THE VACUUM NOZZLE AND PERFORMED SUCCESSFUL CHECKS AND TESTS. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FOR 28 PATIENT SAMPLES ON A COBAS PRO ISE ANALYTICAL UNIT. ONLY 2 EXAMPLES WERE PROVIDED. PATIENT 1: THE INITIAL NA RESULT WAS 155 MMOL/L, AND THE REPEATED RESULT WAS 144 MMOL/L. PATIENT 2: THE INITIAL NA RESULT WAS 150 MMOL/L, AND THE REPEATED RESULT WAS 142 MMOL/L. THE SAMPLES WERE REPEATED BECAUSE THE PHYSICIAN QUESTIONED THE RESULTS. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213400 COBAS PRO ISE ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1