BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS PRO ISE ANALYTICAL UNIT

    MDR report key: 20063878 · Received August 26, 2024

    Report

    Report Number
    1823260-2024-02470
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    August 3, 2024
    Report Date
    September 20, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS PRO ISE ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER FOUND AN ISSUE WITH THE ELECTRODES AND POTENTIAL ISE FLOW PATH CONTAMINATION. HE REPLACED SODIUM, CHLORIDE, AND REFERENCE ELECTRODES, PERFORMED ISE FLOW PATH WASH, AND RAN MULTIPLE GREEN RACKS. THE ISE CHECKS HAD NO ISSUES AND PRECISION TESTING AND QC WERE ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE. MEDWATCH FIELDS D1-D4, G1, AND G4 WERE UPDATED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS PRO ISE ANALYTICAL UNIT. THE SAMPLE WAS REPEATED ON A DIFFERENT COBAS C503 ANALYZER. THE INITIAL CHLORIDE RESULT WAS 112 MMOL/L AND THE REPEAT RESULT WAS 100.6 MMOL/L. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND WERE QUESTIONED BY THE ER PHYSICIAN. THIS MEDWATCH WILL ADDRESS THE QUESTIONABLE CHLORIDE RESULTS. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER PT-0070513 FOR THE SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279822 COBAS PRO ISE ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS G37

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female