BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET II

    MDR report key: 23941757 · Received January 2, 2026

    Report

    Report Number
    3003442380-2025-17724
    Event Type
    Injury
    Date Received
    January 2, 2026
    Date of Event
    November 27, 2025
    Report Date
    February 5, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244021099
    PMA / PMN Number
    K032854
    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) MDR 3003442380-2025-17724- DEVICE 1 OF 5.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01- (B)(4) - MDR 3003442380-2025-17724. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER UNDER D4 AND MANUFACTURING DATE UNDER H4. 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: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 04-FEB-2026 AGAINST "LOT NUMBER 6011718 AND SIMILAR MALFUNCTION CODES: INSERTION INTO SCAR TISSUE, IMPROPER SITE SELECTION, OR INCORRECT PREPARATION OF SET, SET BROKE PRIOR TO USE DUE TO INSERTION INTO SCAR TISSUE, INTO SITES NOT STATED BY THE IFU, OR INCORRECT PREPARATION OF SET. THE REVIEW CONFIRMED THAT LOT 6011718 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 04-FEB-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6011718 AND SIMILAR MALFUNCTION CODES INSERTION INTO SCAR TISSUE, IMPROPER SITE SELECTION, OR INCORRECT PREPARATION OF SET, SET BROKE PRIOR TO USE DUE TO INSERTION INTO SCAR TISSUE, INTO SITES NOT STATED BY THE IFU, OR INCORRECT PREPARATION OF SET. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBERS ARE COMPLAINT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011718 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 AND MANUFACTURED IN THE LINE 07, ON 01-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED IN ACCORDANCE WITH APPLICABLE PROCEDURES. ALL REQUIRED IN-PROCESS AND FINAL TESTS WERE COMPLETED AND MET SPECIFIED REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED THAT RELATE TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS; NO ISSUES NOTED. VISUAL EVIDENCE REVIEW: NO PHOTO WAS PROVIDED TO SUPPORT VISUAL CONFIRMATION OF THE REPORTED ISSUE. CONCLUSION: UNABLE TO PERFORM VISUAL VERIFICATION; ASSESSMENT BASED ON AVAILABLE DOCUMENTATION ONLY. RETAIN SAMPLES TESTING: NO DEVICE, COMPONENTS, OR PHYSICAL EVIDENCE WERE AVAILABLE FOR EVALUATION; THEREFORE, VISUAL INSPECTION AND RETAIN-SAMPLE TESTING COULD NOT BE PERFORMED. BASED ON THE EVENT DESCRIPTION, ASSIGNED MALFUNCTION CODE, AND THE LIMITED INFORMATION PROVIDED, THE REPORTED FAILURE COULD NOT BE CONFIRMED. CONCLUSION: NO FURTHER INVESTIGATION ACTIVITIES WERE REQUIRED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI (MONTHLY TRIPS AND ALERTS). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING, A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING EQMS QUERIES, SIMILAR COMPLAINT SEARCHES, DEVICE HISTORY RECORD REVIEW, VISUAL EVIDENCE ASSESSMENT, AND CAPA DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6011718 AND RELATED MALFUNCTION CODES. ONE COMPLAINT WAS IDENTIFIED FOR THIS LOT; HOWEVER, NO TREND OR SYSTEMIC ISSUE WAS DETECTED. THE MANUFACTURING RECORDS CONFIRMED THAT THE LOT WAS PRODUCED IN COMPLIANCE WITH ALL REQUIREMENTS, WITH NO DEVIATIONS OR MAINTENANCE EVENTS NOTED. NO DEVICE, COMPONENTS, OR PHYSICAL EVIDENCE WERE AVAILABLE FOR EVALUATION; THEREFORE, VISUAL INSPECTION AND RETAIN-SAMPLE TESTING COULD NOT BE PERFORMED. BASED ON THE EVENT DESCRIPTION, ASSIGNED MALFUNCTION CODE, AND THE LIMITED INFORMATION PROVIDED, THE REPORTED FAILURE COULD NOT BE CONFIRMED

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED TUBING LEAKAGE ISSUE WITH FIVE INFUSION SETS ON (B)(6) 2025. THE TUBING WAS LEAKING AT SITE. THE PATIENT WENT TO EMERGENCY ROOM (ER) AND STAYED THERE FOR 4 HOURS. THE INFUSION SET WAS IN USE FOR 1-2 DAYS. THE PATIENT BLOOD GLUCOSE (BG) WAS BELOW 600 MG/DL AND WAS TREATED INTRAVENOUSLY WITH FLUIDS OF SALINE AND INSULIN. THE PATIENT WAS RELEASED FROM HOSPITAL ON (B)(6) 2025. THE PATIENT REPLACED THE 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
    5500 INSET II UNO INSET I 80/6 GREY TCAP 10PACK US FPA UNOMEDICAL DEVICES S.A. DE C.V. 1003912 6011718 05705244021099

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention| H