BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS PRO ISE ANALYTICAL UNIT

    MDR report key: 19536170 · Received June 14, 2024

    Report

    Report Number
    1823260-2024-01770
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 17, 2024
    Report Date
    June 14, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE CUSTOMER'S CALIBRATION AND QC WERE ACCEPTABLE. THE FIELD SERVICE REPRESENTATIVE FOUND THE CAUSE OF THE ISSUE WAS A LOOSE VACUUM NOZZLE THUMB SCREW. HE CHECKED THE ISE GEAR PUMP PRESSURE, RINSE VOLUMES, SAMPLE PROBE ADJUSTMENTS, AND CLEANED THE DILUTION VESSEL AND ISE ELECTRODE FLOWPATH. HE SECURED THE VACUUM NOZZLE THUMB SCREW, PERFORMED PRIMES AND ISE CHECKS. ISE CALIBRATION, QC, AND PRECISION CHECKS WERE ACCEPTABLE. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE NA ELECTRODE RESULTS FOR 16 PATIENT SAMPLES ON A COBAS PRO ISE ANALYTICAL UNIT. PATIENT 1 (ID: (B)(6): THE INITIAL RESULT WAS 156 MEQ/L AND THE REPEATED RESULT WAS 138 MEQ/L. PATIENT 2 (ID: (B)(6): THE INITIAL RESULT WAS 151 MEQ/L AND THE REPEATED RESULT WAS 136 MEQ/L. PATIENT 3 (ID: (B)(6): THE INITIAL RESULT WAS 153 MEQ/L AND THE REPEATED RESULT WAS 139 MEQ/L. PATIENT 4 (ID: (B)(6): THE INITIAL RESULT WAS 153 MEQ/L AND THE REPEATED RESULT WAS 138 MEQ/L. PATIENT 5 (ID: (B)(6): THE INITIAL RESULT WAS 156 MEQ/L AND THE REPEATED RESULT WAS 141 MEQ/L. PATIENT 6 (ID: (B)(6): THE INITIAL RESULT WAS 151 MEQ/L AND THE REPEATED RESULT WAS 138 MEQ/L. PATIENT 7 (ID: (B)(6): THE INITIAL RESULT WAS 124 MEQ/L AND THE REPEATED RESULT WAS 108 MEQ/L. PATIENT 8 (ID: (B)(6): THE INITIAL RESULT WAS 141 MEQ/L AND THE REPEATED RESULT WAS 125 MEQ/L. PATIENT 9 (ID: (B)(6): THE INITIAL RESULT WAS 163 MEQ/L AND THE REPEATED RESULT WAS 144 MEQ/L. PATIENT 10 (ID: (B)(6): THE INITIAL RESULT WAS 157 MEQ/L AND THE REPEATED RESULT WAS 141 MEQ/L. PATIENT 11 (ID: (B)(6): THE INITIAL RESULT WAS 157 MEQ/L AND THE REPEATED RESULT WAS 141 MEQ/L. PATIENT 12 (ID: (B)(6): ON 18-MAY-2024 THE INITIAL RESULT WAS 153 MEQ/L AND THE REPEATED RESULT WAS 138 MEQ/L. PATIENT 13 (ID: (B)(6): ON 18-MAY-2024 THE INITIAL RESULT WAS 156 MEQ/L AND THE REPEATED RESULT WAS 139 MEQ/L. PATIENT 14 (ID: (B)(6): ON 18-MAY-2024 THE INITIAL RESULT WAS 158 MEQ/L AND THE REPEATED RESULT WAS 142 MEQ/L. PATIENT 15 (ID: (B)(6): ON 18-MAY-2024 THE INITIAL RESULT WAS 158 MEQ/L AND THE REPEATED RESULT WAS 138 MEQ/L. PATIENT 16 (ID: (B)(6): ON 18-MAY-2024 THE INITIAL RESULT WAS 153 MEQ/L AND THE REPEATED RESULT WAS 138 MEQ/L. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER ANALYZER. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS WERE QUESTIONED BY THE PHYSICIAN AND THE SAMPLES WERE REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369246 COBAS PRO ISE ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown