BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 23519883 · Received November 11, 2025

    Report

    Report Number
    3003442380-2025-16051
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    April 24, 2025
    Report Date
    November 12, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - DEVICE 2 OF 4.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2025-16051. 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 UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6013546 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013546 WAS PACKAGING ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 123 AND MANUFACTURED IN THE LI 49, ON 31/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING. THE LOT 5E02281 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 68 AND MANUFACTURED IN THE MACHINE SC03, ON 28-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E00696 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 10 AND MANUFACTURED IN THE MACHINE ITL01, ON 30-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E02280 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 68 AND MANUFACTURED IN THE MACHINE SC01, ON 29-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E02278 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 10 AND MANUFACTURED IN THE MACHINE ITL01, ON 31-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E02282 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 68 AND MANUFACTURED IN THE MACHINE SC01, ON 31-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5F00130 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 68 AND MANUFACTURED IN THE MACHINE SC03, ON 01-JUN-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.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SET TUBING DETACHMENT FROM HUB EVENT ON (B)(6) 2025. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492942 INSET II UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002817 6013546 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female