BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET 30

    MDR report key: 23475572 · Received November 5, 2025

    Report

    Report Number
    3003442380-2025-15851
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 12, 2025
    Report Date
    November 27, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244016651
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER 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 6013378, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR)REVIEW: THE LOT 6013378 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 123 IN THE LINE 08, ON 25/MAY/2025, WITH A TOTAL OF (B)(4) UNITS THE SUB-ASSEMBLY: GLUING OF TUBING THE LOT 5E00714 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 3 AND MANUFACTURED IN THE MACHINE ITL03, ON 20-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E00713 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 3 AND MANUFACTURED IN THE MACHINE ITL03, ON 20-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5D01203 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 3 AND MANUFACTURED IN THE MACHINE ITL03, ON 23-ABR-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. REVIEW OF THE DHR SHOWED THAT DURING THE OUTGOING TEST 6 AN EXTENDED WAS FOUND FOR CONTAMINATION IN ONE TUBE AND THEREFORE 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.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SET DETACHMENT EVENTS ON (B)(6) 2025. THE SITE OF DETACHMENT WAS FROM CONNECTOR. THE INFUSION SET WAS IN USE FOR SIX HOURS. BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF EVENT. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2636320 INSET 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001681 6013378 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female