BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET I

    MDR report key: 22801646 · Received August 14, 2025

    Report

    Report Number
    3003442380-2025-12877
    Event Type
    Injury
    Date Received
    August 14, 2025
    Date of Event
    June 15, 2025
    Report Date
    September 30, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244016620
    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 6010191, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 10-SEP-2025 AGAINST FINAL REPORTING DECISION EQUAL SERIOUS INJURY AND DEATH, LOT NUMBER CRITERIA EQUAL LOT NUMBER 6010191. THE COUNT OF COMPLAINT IS 2 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010191 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 119 AND MANUFACTURED IN THE LINE 08 ON 11-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT A NON-CONFORMANCE (NC) WAS OPENED DURING PRODUCTION PROCESS. BURST TEST "FLOW AND SENSITIVITY PARAMETERS " WERE FOUND INCORRECT ON INSET PRODUCT. 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 THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN INFECTION AT INFUSION SET INSERTION SITE ON (B)(6) 2025. PATIENT DISCUSSED THE INFECTION WITH THE HEALTH CARE PROFESSIONAL (HCP) AND RECIEVED THE MEDICATION FOR THE INFECTION. INFUSION SET WAS USED FOR THREE DAYS WHICH IS AGAINST THE INSTRUCTIONS FOR USE (IFU) GUIDELINES OF INFUSION SET WITH THE GIVEN INSULIN. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES 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
    1626460 INSET I UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001680 6010191 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention