BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET

    MDR report key: 24301186 · Received February 10, 2026

    Report

    Report Number
    3003442380-2026-00392
    Event Type
    Injury
    Date Received
    February 10, 2026
    Date of Event
    January 14, 2026
    Report Date
    March 10, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244016958
    PMA / PMN Number
    K032854
    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 3003442380-2026-00392. 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. 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 10-MAR-2026 AGAINST "LOT NUMBER 6012315 AND SIMILAR MALFUNCTION CODES: MISUSE. MALFUNCTION CODE NOT ON LIST, PRODUCT USED OFF-LABEL OR AGAINST THE CONTRAINDICATIONS OR NOT ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) (ONLY USE IF NO ACTUAL PRODUCT MALFUNCTION HAS BEEN REPORTED). THE REVIEW CONFIRMED THAT LOT 6012315 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NONCONFORMING REPORTS (NCR)S OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 10-MAR-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6012315 AND SIMILAR MALFUNCTION CODES MISUSE. MALFUNCTION CODE NOT ON LIST, PRODUCT USED OFF-LABEL OR AGAINST THE CONTRAINDICATIONS OR NOT ACCORDING TO THE IFU. (ONLY USE IF NO ACTUAL PRODUCT MALFUNCTION HAS BEEN REPORTED). THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBERS ARE (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012315 WAS PACKAGING ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 121, IN THE LINE 05, ON 14-MAR-2025, WITH A TOTAL OF (B)(4). 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 6012315 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.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - DEVICE 3 OF 3.

    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 THE PATIENT FACED INFUSION SET FELL OFF DURING USE ON (B)(6) 2026. THE INFUSION SET WAS IN USE FOR THREE TO FIVE DAYS.THE PATIENT WENT TO EMERGENCY ROOM AND DURATION OF STAY WAS FOR 6 HOURS.THE BLOOD GLUCOSE LEVEL WAS ABOVE 500 MG/DL AND THE PATIENT WAS TREATED WITH INTRAVENOUS AND FLUIDS OF SALINE AND INSULIN.THE PATIENT WAS TESTED POSITIVE FOR KETONES AND IT WAS SERIOUS AND LIFE THREATENING. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2026. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY.THE ISSUE OCCURED WITH 3 INFUSION SETS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350219 INSET UNO INSET I 110/9 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001729 6012315 05705244016958

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Life Threatening| R