BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET

    MDR report key: 24305692 · Received February 10, 2026

    Report

    Report Number
    3003442380-2026-00482
    Event Type
    Injury
    Date Received
    February 10, 2026
    Date of Event
    August 16, 2024
    Report Date
    March 10, 2026
    Manufacturer
    UNOMEDICAL UM-D
    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

    SUPPLEMENTAL REPORT 01 (B)(4) MDR 3003442380-2026-00482. 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 6010871 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 INSTRUCTIONS FOR USE (IFU), OR INCORRECT PREPARATION OF SET. THE REVIEW CONFIRMED THAT LOT 6010871 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 6010871 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 (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010871 WAS PACKAGING ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120, IN THE LINE INSET 10, ON 21-JAN-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 6010871 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 FOR MORE DETAILS, SEE THE INFORMATION UNDER THE CHILD INVESTIGATION RECORD (B)(4).

    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. THIS EMDR IS BEING SUBMITTED FOR UNKNOWN NUMBER OF QUANTITIES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MORE THAN ONE HUNDRED INFUSION SET ISSUES AND PRESENTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2024 DUE TO HYPERGLYCEMIA. INFUSION SITE CHANGES WERE TYPICALLY PERFORMED EVERY FOUR TO FIVE DAYS, WHICH FREQUENTLY LED TO BENT CANNULA EVENTS OCCURRING APPROXIMATELY THREE HOURS AFTER INSERTION. THE PRIMARY INSERTION SITE WAS THE ABDOMEN, WITH REGULAR ROTATION TO OTHER AREAS INCLUDING THE THIGHS, ARMS, AND BUTTOCKS. AT THE TIME OF THE EVENT, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL. TREATMENT CONSISTED OF INTRAVENOUS SALINE AND INSULIN, AND THE LENGTH OF THE EMERGENCY ROOM STAY WAS SIX TO SEVEN HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495069 INSET UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL UM-D 1001680 6010871 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention