BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET II

    MDR report key: 23035328 · Received September 12, 2025

    Report

    Report Number
    3003442380-2025-13663
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    August 29, 2025
    Report Date
    September 16, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Adverse Event
    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 UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6012193, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 12-SEP-2025 AGAINST FINAL REPORTING DECISION EQUAL SERIOUS INJURY AND DEATH, LOT NUMBER CRITERIA EQUAL LOT NUMBER 6012193. THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012193 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 76 AND MANUFACTURED IN THE LINE 6 ON 22-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT A NON-CONFORMANCE (NC) 2174436 PRELIMINARY INVESTIGATION, (THE INNER CYLINDER OF THE COVER PERFORMS A MOVEMENT WHICH DELAMINATES THE TAPE.) FURTHER DATA FROM THIS MONITORING WILL BE ANALYZED BY CORRECTIVE AND PREVENTIVE ACTION (CAPA) 2187040 DELAMINATED ADHESIVE TAPE ON INSET/YPSOMED PRODUCTS. TEST RESULTS: IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE(S) FROM THE LOT HAVE BEEN REQUESTED NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, ONE NC RAISED DURING PRODUCTION PROCESS NO RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION, 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 GERMANY. IT WAS REPORTED THAT PATIENT WAS HAVING KETOACIDOSIS ON (B)(6) 2025 AND TREATED IT WITH USING A DIABETIC REGIMEN. BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF EVENT. THE PATIENT ALSO HAD SYMPTOMS OF HEADACHE AND WAS FEELING UNWELL. THE PATIENT WAS ALSO FOUND POSITIVE FOR HIGH KETONES. THE INFUSION SET WAS IN USE FOR EIGHT HOURS. 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
    2192233 INSET II UNO INSET II 46/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 86-046-52B6 6012193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown