BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CLEO INFUSION SET

    MDR report key: 25143341 · Received May 11, 2026

    Report

    Report Number
    3012307300-2026-04840
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 12, 2026
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586028335
    PMA / PMN Number
    K042172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    PATIENT WITH DIABETES STATED THAT GLUCOSE READINGS WERE HIGH AROUND 9:00 PM. PWD CHANGED THE CANNULA, AFTER WHICH A LINE BLOCKED ALARM WAS RECEIVED. PWD THEN CHANGED BOTH THE CANNULA AND TUBING. AT APPROXIMATELY 2:00 AM, PWD REPORTED THAT GLUCOSE LEVELS WERE STILL HIGH, PROMPTING A CHANGE OF THE CASSETTE AND INFUSION SET. PWD ADMINISTERED A BOLUS TO TREAT THE HIGH GLUCOSE AND WAITED TO SEE IF LEVELS WOULD DECREASE; HOWEVER, GLUCOSE DID NOT DROP. PWD THEN USED INHALABLE INSULIN, WHICH BEGAN TO BRING GLUCOSE LEVELS DOWN. PWD REPORTED GLUCOSE LEVELS IN THE 200 MG/DL RANGE. PER HALO, GLUCOSE WAS READING 185 MG/DL. PWD STATED THAT A LINE BLOCKED ALARM WAS ALSO EXPERIENCED THE PREVIOUS WEEK. PWD FOLLOWED ON-SCREEN TROUBLESHOOTING STEPS, CHECKED THE TUBING (NO KINKS NOTED), AND CHANGED THE INFUSION SITE. DESPITE REPEATING TROUBLESHOOTING STEPS THREE TO FOUR TIMES, THE ALARM PERSISTED. PWD THEN CHANGED THE CASSETTE, WHICH RESOLVED THE ALARM. PWD REQUESTED REPLACEMENTS. ADDRESS WAS CONFIRMED. PSS OFFERED TO SEND AN SMS TO COLLECT LOT NUMBERS FOR THE CASSETTES AND INFUSION SETS, AND PWD AGREED. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THE OPERATOR OF THE DEVICE WAS THE LAY USER OR PATIENT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452956 CADD CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 10610586028335

    Patients

    Seq Age Sex Outcome Treatment
    1