BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 24714658 · Received March 30, 2026

    Report

    Report Number
    3003442380-2026-99531
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    November 8, 2023
    Report Date
    February 25, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244016620
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNOMEDICAL HEREBY SUBMITS THIS INITIAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CAPA/FDA ACTION PLAN. THIS SUBMISSION INCLUDES A RETROSPECTIVE REASSESSMENT OF PREVIOUSLY EVALUATED COMPLAINTS. UNO MEDICAL IS PROVIDING THIS INITIAL INFORMATION IN ACCORDANCE WITH THE REPORTING REQUIREMENTS SET FORTH IN 21 CFR PART 803. ANY FIELDS LEFT BLANK INDICATE THAT THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR REMAIN UNCHANGED. BASED ON THE REVIEW COMPLETED ON 25-FEB-2026 AND INVESTIGATION COMPLETED ON 09-MAR-2026 THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED AS THE INITIAL REPORT. ADDITIONAL INFORMATION - THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY THIS INVESTIGATION HAS BEEN UPDATED BECAUSE THE MALFUNCTION CODE CHANGED FROM TUBING CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE) TO LEAK BETWEEN TUBING AND PUMP CONNECTOR/HUB - DETACHMENT /SIGNIFICANT WETNESS, WHICH REQUIRES ADDITIONAL ACTIVITIES NOT INCLUDED IN THE ORIGINAL INVESTIGATION DATED 21-NOV-2023 THE ORIGINAL INVESTIGATION REMAINS VALID AND HAS NOT BEEN MODIFIED. AS PART OF THIS REASSESSMENT, THE FOLLOWING ELEMENTS WERE ADDED TO ALIGN WITH CURRENT INVESTIGATION REQUIREMENTS: COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 09-MAR-2026 AGAINST LOT NUMBER 6000574 AND SIMILAR MALFUNCTION CODES: TUBING DETACHED FROM HUB, LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING), LEAK BETWEEN TUBING AND PUMP CONNECTOR/HUB - DETACHMENT /SIGNIFICANT WETNESS THE REVIEW CONFIRMED THAT LOT 6000574 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NON-CONFORMANCE REPORT (NCR) OR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 09-MAR-2026 AGAINST LOT NUMBER CRITERIA EQUAL 6000574 AND SIMILAR MALFUNCTION CODES: TUBING DETACHED FROM HUB, LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING), LEAK BETWEEN TUBING AND PUMP CONNECTOR/HUB - DETACHMENT /SIGNIFICANT WETNESS THE NUMBER OF COMPLAINTS IS (B)(4). THE COMPLAINT NUMBERS ARE COMPLAINT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 5408165 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 103 AND MANUFACTURED IN INSET 6 LINE ON 29/APR/2023 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: TUBE GLUING LOT 3C04218 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND ASSEMBLED IN THE SC03 LINE, ON 21-MAR-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3C06760 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND ASSEMBLED IN THE SC02 LINE, ON 12-APR-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3D03089 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND ASSEMBLED IN THE SC01 LINE, ON 26-FEB-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3D03084 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND ASSEMBLED IN THE SC02 LINE, ON 28-APR-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3D03185 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND ASSEMBLED IN THE SC03 LINE, ON 29-APR-2023, 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. CAPA DETERMINATION ASSESSMENT - CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: THE INVESTIGATION FOR THIS COMPLAINT WAS PREVIOUSLY COMPLETED ON 21-NOV-2023 UNDER CHILD COMPLAINT INVESTIGATION RECORD (B)(4). THE INVESTIGATION HAS BEEN REVISED TO REFLECT THE UPDATED MALFUNCTION CODE AND NEW REPORTABILITY REQUIREMENTS. THE ORIGINAL INVESTIGATION REMAINS VALID AND HAS NOT BEEN MODIFIED. AS PART OF THIS REASSESSMENT, AN UPDATED EQMS SEARCH WAS PERFORMED WHICH IDENTIFIED ONE RELATED COMPLAINT FOR LOT 6000574. NO NCRS, CAPAS, TRENDS, OR SYSTEMIC ISSUES WERE FOUND. AS REQUIRED UNDER THE UPDATED REPORTABILITY CRITERIA, A FULL DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED. ALL IN PROCESS AND FINAL INSPECTIONS MET SPECIFICATION REQUIREMENTS, AND NO DEVIATIONS, REWORK ACTIVITIES, OR MAINTENANCE EVENTS ASSOCIATED WITH THE MALFUNCTION WERE IDENTIFIED. NO VISUAL EVIDENCE WAS AVAILABLE TO SUPPORT CONFIRMATION OF THE REPORTED ISSUE. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THE EXPANDED INVESTIGATION INCLUDING UPDATED EQMS SEARCHES AND THE DHR REVIEW NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI (MONTHLY TRIPS AND ALERTS) CAPA DETERMINATION = NO CAPA REQUIRED. COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE MALFUNCTION REMAINS UNCONFIRMED FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET DETACHMENT ISSUE ON (B)(6) 2023. THE PATIENT REPORTED INFUSION SET TUBING DETACHED FROM CONNECTOR. THE INFUSION SET WAS IN USE FOR TWELVE HOURS AND BLOOD GLUCOSE WAS 123 MG/DL AT THE TIME OF EVENT. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775327 INSET UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL UM-D 1001680 6000574 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female