BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 23590651 · Received November 19, 2025

    Report

    Report Number
    3003442380-2025-16755
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    August 15, 2025
    Report Date
    November 26, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244016620
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2025-16755. A SUPPLEMENTAL MEDICAL DEVICE REPORT (MDR) WAS SUBMITTED ON NOVEMBER 27, 2025, WITH THE MANUFACTURING REPORT NUMBER (MFR) 3003442380-2024-16755, 3003442380-2024-16756 AND 3003442380-2024-16757. DUE TO AN MFR DISCREPANCY, THIS REPORT WAS SUBMITTED UNDER CASE ID (B)(4) BY ERROR. THEREFORE, THIS CURRENT SUPPLEMENTAL MDR IS BEING FILED TO CORRECT THE ASSOCIATED MFR, WHICH SHOULD BE LINKED TO CASE ID (B)(4). SUPPLEMENTAL REPORT 01 - CASE ID (B)(4) - MDR 3003442380-2025-16755 SUPPLEMENTAL REPORT 01 - CASE ID (B)(4) - MDR 3003442380-2025-16756 SUPPLEMENTAL REPORT 01 - CASE ID (B)(4) - MDR 3003442380-2025-16757 THE REPORT NUMBERS BEING RETRACTED ARE AS FOLLOWS: SUPPLEMENTAL REPORT 01 - CASE ID (B)(4) - MDR 3003442380-2024-16755. SUPPLEMENTAL REPORT 01 - CASE ID (B)(4) - MDR 3003442380-2024-16756. SUPPLEMENTAL REPORT 01 - CASE ID (B)(4) - MDR 3003442380-2024-16757. THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (3003442380-2025-16755), WAS SUBMITTED ON 19-NOV-2025. UPON RECEIVING ADDITIONAL INFORMATION FROM MANUFACTURER ON 24-NOV-2025, IT WAS DISCOVERED THAT THE MALFUNCTION CODE EARLIER REPORTED TUBING DETACHED FROM HUB HAS BEEN NOW CHANGED TO LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 22-MAY-2025. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: B5: DESCRIBE EVENT OR PROBLEM. H6: MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED TO REVIEW THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH THE REPORTED ISSUE. THE BATCH 6013376 , IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013376 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 123 IN THE L185 ON 22/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING THE LOT 5E00712 WAS MANUFACTURED ACCORDING TO THE FORM-001865 VERSION 3 AND MANUFACTURED IN THE MACHINE ITL03, ON 17-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5D03618 WAS MANUFACTURED ACCORDING TO THE FORM- 001865 VERSION 3 AND MANUFACTURED IN THE MACHINE ITL03, ON 23-APR-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E00711 WAS MANUFACTURED ACCORDING TO THE FORM- 001865 VERSION 3 AND MANUFACTURED IN THE 03, ON 13-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL (B)(4) - DEVICE 1 OF 3.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2025, (B)(6) 2025, (B)(6) 2025. THE SET WAS IN USE FOR 6 HOURS OR 7 HOURS. THE LEAKAGE WAS AT T:LOCK. THE BLOOD GLUCOSE LEVEL WAS 600 MG/DL AND THE PATIENT WAS TREATED WITH CORRECTION BOLUS VIA PUMP FOR (B)(6) 2025 AND THEN AN INJECTION FOR (B)(6) 2025 AND MANUAL INJECTION FOR (B)(6) 2025. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED AN ISSUE WHERE THE INFUSION SET TUBING DETACHED FROM THE HUB. THIS OCCURRED ON (B)(6) 2025, (B)(6) 2025, AND (B)(6) 2025. THE INFUSION SET WAS IN USE FOR APPROXIMATELY 6-7 HOURS. THE PATIENT'S BLOOD GLUCOSE LEVEL REACHED 600 MG/DL ON ALL THREE OCCASIONS. TO ADDRESS THE HIGH BLOOD GLUCOSE, THE PATIENT GAVE A MANUAL INJECTION ON (B)(6) 2025, TOOK A CORRECTION BOLUS VIA PUMP ON (B)(6) 2025, AND ADMINISTERED AN INJECTION ON (B)(6) 2025. THE PATIENT REPLACED THE INFUSION SET AND SUCCESSFULLY RESUMED INSULIN DELIVERY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2874775 INSET UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001680 6013376 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female