BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 22779759 · Received August 11, 2025

    Report

    Report Number
    3003442380-2025-12749
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 28, 2025
    Report Date
    September 29, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018181
    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. REVISION 21 OF (B)(4) DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6012410, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012410 WAS MANUFACTURED ACCORDING TO THE WI VERSION 121 AND MANUFACTURED IN THE LINE 4 ON 26-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, TUBE GLUING OF THE LOT 5C05417 WAS MANUFACTURED ACCORDING TO THE WI VERSION 67 AND MANUFACTURED IN THE MACHINE SC09, ON 26-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, TUBE GLUING OF THE LOT 5C01542 WAS MANUFACTURED ACCORDING TO THE WI VERSION 9 AND MANUFACTURED IN THE MACHINE ITL01, ON 27-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, TUBE GLUING OF THE LOT 5C01528 WAS MANUFACTURED ACCORDING TO THE WI VERSION 9 AND MANUFACTURED IN THE MACHINE ITL01, ON 23-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT A NON-CONFORMANCES NC 2181127 WAS RAISED DURING THE MANUFACTURING PROCESS (LACK OF DOCUMENTATION). THIS NC IS NOT RELATED TO CLAIMED MALFUNCTION. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: ONE NONCONFORMANCE (NC) WAS RAISED DURING THE MANUFACTURING PROCESS, AND FOUND UNRELATED TO THE REPORTED 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 THE PATIENT FACED AN INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. THE BLOOD GLUCOSE LEVEL WAS HIGH (SPECIFIC VALUE UNKNOWN) AT THE TIME OF EVENT AND THE PATIENT WAS TREATED WITH CORRECTION INJECTION VIA MULTIPLE DAILY INJECTIONS (MDI). 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
    1339630 INSET II UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002819 6012410 05705244018181

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female