BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS PRO ISE ANALYTICAL UNIT

    MDR report key: 24518347 · Received March 5, 2026

    Report

    Report Number
    1823260-2026-00775
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 11, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS PRO ISE ANALYZER SERIAL NUMBER WAS (B)(6).

    Additional Manufacturer Narrative · 0

    SECTION D, DEVICE IDENTIFICATION, WAS UPDATED. RELEVANT FIELDS OF SECTIONS D AND G WERE UPDATED. THE NA ELECTRODE WAS EQL WITH AN EXPIRATION DATE OF 27-JUL-2026.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF QC ISSUES ON A COBAS PRO ISE ANALYTICAL UNIT. THE CUSTOMER REPLACED THE ELECTRODES, PERFORMED A PROBE WASH, COMPLETED CONDITIONING, AND PERFORMED PRECISION TESTING, WITH ACCEPTABLE RESULTS. THE CUSTOMER PERFORMED A REVIEW OF PATIENT RESULTS THAT HAD BEEN REPORTED OUTSIDE OF THE LABORATORY AND PERFORMED REPEAT TESTING ON A DIFFERENT COBAS PRO ISE ANALYZER. DISCREPANT RESULTS WERE IDENTIFIED FOR 4 PATIENT SAMPLES TESTED FOR SODIUM ELECTRODE (NA) AND ISE INDIRECT NA-K-CL FOR GEN.2 (CL). THIS MEDWATCH WILL COVER NA. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER PT-0084466 FOR INFORMATION ON THE CL RESULTS. PATIENT 1 INITIAL NA RESULT WAS 156 MMOL/L. THE REPEAT RESULT WAS 142 MMOL/L. THE INITIAL CL RESULT WAS 113 MMOL/L. THE REPEAT RESULT WAS 102 MMOL/L. PATIENT 2 INITIAL NA RESULT WAS 148 MMOL/L. THE REPEAT RESULT WAS 139 MMOL/L. PATIENT 3 INITIAL NA RESULT WAS 154 MMOL/L. THE REPEAT RESULT WAS 147 MMOL/L. PATIENT 4 INITIAL NA RESULT WAS 151 MMOL/L. THE REPEAT RESULT WAS 139 MMOL/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626618 COBAS PRO ISE ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS EQL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown