BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET 30

    MDR report key: 22696935 · Received August 4, 2025

    Report

    Report Number
    3003442380-2025-12220
    Event Type
    Injury
    Date Received
    August 4, 2025
    Date of Event
    July 16, 2024
    Report Date
    August 13, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018365
    PMA / PMN Number
    K061374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) MDR 3003442380-2025-12220. 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. THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6012086 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE LEAKAGE FROM INFUSION SITE (SPECIFIC CAUSE NOT IDENTIFIED) NOT CONFIRMED TO BE INFUSION SET RELATED (EX. TISSUE NO LONGER ABSORBING). COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST AIR FLOW ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST AIR LEAK ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012086 WAS MANUFACTURED ACCORDING TO THE WI VERSION 30 MANUFACTURED IN THE LINE 7, ON 06/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 11/AUG/2025 AGAINST MALFUNCTION LEAKAGE FROM INFUSION SITE (SPECIFIC CAUSE NOT IDENTIFIED) NOT CONFIRMED TO BE INFUSION SET RELATED (EX. TISSUE NO LONGER ABSORBING) AND LOT 6012086 AND NO OTHER COMPLAINTS HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, 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.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4). DEVICE 1 OF 2.

    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 INFUSION SETS TUBING LEAKAGE AT SITE EVENTS BETWEEN (B)(6) 2024 TO (B)(6) 2025. INFUSION SETS WERE USED FOR LESS THAN 72 HOURS. BLOOD GLUCOSE LEVEL WAS DISPLAYED HIGH AT THE TIME OF THE EVENT DUE TO WHICH PATIENT REQUIRED ASSISTANCE FROM HOSPITAL STAFF AND GOT TREATED WITH FLUIDS AND INSULIN VIA INTRAVENOUS (IV) DRIPS. PATIENT FELL DOWN AND HIT THEIR HEAD ON THE WALL WHICH RESULTED IN BRUISING AT THE TIME OF THE EVENT. PATIENT WAS FOUND POSITIVE FOR KETONES. PATIENT REPLACED THE INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1571725 INSET 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002825 6012086 05705244018365

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female Required Intervention