BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 20799949 · Received November 27, 2024

    Report

    Report Number
    1823260-2024-03470
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 10, 2024
    Report Date
    January 9, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    07613336220153
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE INITIAL MEDWATCH, THE FIRST LINE OF B5 DESCRIBE EVENT OR PROBLEM SHOULD HAVE BEEN: "THE INITIAL REPORTER RECEIVED QUESTIONABLE K ELECTRODE RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS C 303 ANALYTICAL UNIT.". INSTEAD OF: "THE INITIAL REPORTER RECEIVED QUESTIONABLE K ELECTRODE RESULTS FROM THREE PATIENT SAMPLES TESTED ON THE COBAS C 303 ANALYTICAL UNIT.". THE CUSTOMER STATED THAT THE QCS WERE WITHIN THE SPECIFIED RANGES. THE CUSTOMER DID NOT REPORT ANY OTHER ISSUES AFTER SERVICE. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER INSPECTED THE ANALYZER AND PERFORMED ION-SELECTIVE ELECTRODE (ISE) CHECKS, FAILING FOR K. HE FOUND LIQUID BETWEEN THE ELECTRODES. HE THEN CLEANED AND RESET THE ELECTRODES AND LET THE ACTIVATOR SET IN THE ELECTRODES FOR 15 MINUTES. HE VERIFIED THE ANALYZER'S PERFORMANCE BY SUCCESSFUL ISE AND PRECISION CHECKS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE K ELECTRODE RESULTS FROM THREE PATIENT SAMPLES TESTED ON THE COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 8.16 MMOL/L. THE REPEAT RESULT WAS 3.79 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT. THE INITIAL RESULT WAS DEEMED UNUSUALLY HIGH AND WAS NOT REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831356 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 07613336220153

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male