BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 19414373 · Received May 29, 2024

    Report

    Report Number
    1823260-2024-01587
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    April 26, 2024
    Report Date
    July 17, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER PERFORMED PREVENTIVE MAINTENANCE ON THE ISE UNIT. HE DECONTAMINATED THE ISE MODULE AND REPLACED THE DILUTION CUP, SIPPER NOZZLE, AND ELECTRODES. HE PRIMED THE ISE AND RAN ISE CHECKS THAT WERE ACCEPTABLE. THE CUSTOMER PERFORMED DAILY SETUP, CALIBRATION, AND QC THAT WERE ACCEPTABLE. THE CUSTOMER RAN PATIENT SAMPLES AND ACCEPTED THE RESULTS. THE INVESTIGATION DID NOT IDENTIFY THE SPECIFIC CAUSE OF THE EVENT. THE ISSUE WAS RESOLVED AFTER THE SERVICE ACTIONS.

    Additional Manufacturer Narrative · 0

    THE ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.. THE FIELD SERVICE ENGINEER MODIFIED THE SHIM TAPE KIT, REPLACED THE SIPPER NOZZLE, AND PERFORMED ISE PRIMES AND ISE CHECKS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM RESULTS FROM THE COBAS PURE C 303 ANALYTICAL UNIT. SAMPLE (B)(4) INITIAL RESULT WAS 148.9 MMOL/L AND THE REPEAT RESULT WAS 141.4 MMOL/L. SAMPLE (B)(4) INITIAL RESULT WAS 147.6 MMOL/L AND THE REPEAT RESULT WAS 142.1 MMOL/L. SAMPLE (B)(4) INITIAL RESULT WAS 148.9 MMOL/L AND THE REPEAT RESULT WAS 140.8 MMOL/L. SAMPLE (B)(4) INITIAL RESULT WAS 150.3 MMOL/L AND THE REPEAT RESULT WAS 141.9 MMOL/L. SAMPLE (B)(4) INITIAL RESULT WAS 149.6 MMOL/L AND THE REPEAT RESULT WAS 143.3 MMOL/L. SAMPLE (B)(4) INITIAL RESULT WAS 148.3 MMOL/L AND THE REPEAT RESULT WAS 141.9 MMOL/L. SAMPLE (B)(4) INITIAL RESULT WAS 149.4 MMOL/L AND THE REPEAT RESULT WAS 141.8 MMOL/L. SAMPLE (B)(4) INITIAL RESULT WAS 149.9 MMOL/L AND THE REPEAT RESULT WAS 143.6 MMOL/L. SAMPLE (B)(4) INITIAL RESULT WAS 150.5 MMOL/L AND THE REPEAT RESULT WAS 143.2 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824978 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown