BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET 30

    MDR report key: 23070566 · Received September 17, 2025

    Report

    Report Number
    3003442380-2025-13874
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    August 21, 2025
    Report Date
    September 12, 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

    INITIAL AND FINAL MDR (B)(4). DEVICE 2 OF 2. 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 6011115, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 11-SEP-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL 6011115. THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DHR REVIEW: THE LOT 6011115 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 29 AND MANUFACTURED IN THE MULTIVAC INSET 30 - L1 ON 16-JAN-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. TEST RESULTS: NO PHOTO WAS PROVIDED. IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE FROM THE LOT HAVE BEEN REQUESTED. NO RETURNED SAMPLES. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION 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.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED ADHESIVE ISSUES WITH TWO INFUSION SETS, BOTH EXPERIENCING THE SAME TYPE OF PROBLEM. SPECIFICALLY, THE PATIENT REPORTED THAT THE INFUSION SET PATCH CANNULA WAS COMING OUT OF THE SKIN. THESE EVENTS OCCURRED BETWEEN (B)(6) 2025. THE INFUSION SETS WERE IN USE FOR UP TO TWO DAYS. THE ISSUE CAUSED THE PATIENT'S BLOOD GLUCOSE (BG) TO REACH 450 MG/DL. TO ADDRESS THE HIGH BG, THE CUSTOMER ADMINISTERED A CORRECTION BOLUS VIA PUMP. DUE TO THE ELEVATED BG LEVEL, THE CUSTOMER REQUIRED THIRD-PARTY ASSISTANCE FROM THE EMERGENCY ROOM (ER), WHERE THEY RECEIVED FLUIDS AND INSULIN TREATMENT INTRAVENOUSLY (IV). THE ER VISIT OCCURRED ON (B)(6) 2025 AND LASTED FIVE HOURS. THE EVENT DID NOT CAUSE ANY INJURY. IT IS UNKNOWN WHETHER THE PATIENT'S HAD KETONES, AS THEY DID NOT TEST FOR KETONES. THE PATIENT RESOLVED THE ISSUE BY REPLACING THE INFUSION SET AND SUCCESSFULLY RESUMING INSULIN DELIVERIES. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731977 INSET 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002825 6011115 05705244018365

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention