BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS PRO ISE ANALYTICAL UNIT

    MDR report key: 19741595 · Received July 15, 2024

    Report

    Report Number
    1823260-2024-02027
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 17, 2024
    Report Date
    September 30, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CALIBRATION AND QC WERE ACCEPTABLE. THE FIELD SERVICE REPRESENTATIVE FOUND THE VACUUM NOZZLE COLLAR WAS MISSING, CAUSING THE NOZZLE TO WIGGLE AND THE THUMB SCREW WAS OUT OF PLACE. THE COLLAR AND BOTH NOZZLES WERE REPLACED. CHECKS AND TESTS WERE PERFORMED AND THE RESULTS WERE ACCEPTABLE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE FOUND THE VACUUM NOZZLE COLLAR WAS MISSING. THE FSE REPLACED THE COLLAR, SIPPER NOZZLE, VACUUM NOZZLE, AND DEGASSER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE NA ELECTRODE AND CL ELECTRODE RESULTS FOR 1 PATIENT AND QUESTIONABLE NA ELECTRODE RESULTS FOR 5 PATIENTS ON A COBAS PRO ISE ANALYTICAL UNIT. PATIENT 1: SAMPLE A (ID: (B)(6) ): THE INITIAL NA RESULT WAS 156 MMOL/L. THE INITIAL CL RESULT WAS 119. A NEW SAMPLE (SAMPLE B (ID: (B)(6) ) WAS OBTAINED AND THE NA RESULT WAS 154 MMOL/L AND THE CL RESULT WAS 119. SAMPLE A: THE REPEATED NA RESULT WAS 140 MMOL/L AND THE REPEATED CL RESULT WAS 107. SAMPLE B: THE REPEATED NA RESULT WAS 140 MMOL/L AND THE REPEATED CL RESULT WAS 107. THE UNIT OF MEASURE FOR THE CL TEST WAS NOT PROVIDED. PATIENT 2 (ID: (B)(6) ). THE INITIAL NA RESULT WAS 158 MMOL/L AND THE REPEATED RESULT WAS 142 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 142 MMOL/L. PATIENT 3 (ID: (B)(6) ). THE INITIAL NA RESULT WAS 158 MMO/L AND THE REPEATED RESULT WAS 139 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 139 MMOL/L. PATIENT 4 (ID: (B)(6) ): THE INITIAL NA RESULT WAS 152 MMOL/L AND THE REPEATED RESULT WAS 138 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 139 MMOL/L. PATIENT 5 (ID: (B)(6) ): THE INITIAL NA RESULT WAS 146 MMOL/L AND THE REPEATED RESULT WAS 140 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 140 MMOL/L. PATIENT 6 (ID: (B)(6) ): THE INITIAL NA RESULT WAS 147 MMOL/L AND THE REPEATED RESULT WAS 140 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 141 MMOL/L. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE SAMPLES WERE ALL REPEATED ON 19-JUN-2024. THE SAMPLES WERE REPEATED DUE TO THE INITIAL RESULTS BEING QUESTIONED BY A PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498562 COBAS PRO ISE ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown