BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 23972174 · Received January 6, 2026

    Report

    Report Number
    3003442380-2025-17953
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    November 30, 2025
    Report Date
    February 24, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    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

    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 12-FEB-2026 AGAINST "LOT NUMBER 6013783 AND SIMILAR MALFUNCTION CODES: ADHESIVE PATCH COMPLETELY DETACHES DURING USE-DETACHMENT / SIGNIFICANT WETNESS, ADHESIVE PATCH LIFTS OR DETACHES DURING USE (ONLY USE FOR CONFIRMED ADHESIVE ISSUE, REFER TO CANNOT BE DETERMINED) . THE REVIEW CONFIRMED THAT LOT 6013783 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 12-FEB-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6013783 AND SIMILAR MALFUNCTION CODES ADHESIVE PATCH COMPLETELY DETACHES DURING USE- DETACHMENT / SIGNIFICANT WETNESS, ADHESIVE PATCH LIFTS OR DETACHES DURING USE (ONLY USE FOR CONFIRMED ADHESIVE ISSUE, REFER TO CANNOT BE DETERMINED). THE COUNT OF COMPLAINT IS 4. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013783 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 124 AND MANUFACTURED IN THE LINE 10 ON 17-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. CAPA DETERMINATION ASSESSMENT - CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE ABOVE INVESTIGATION, FURTHER INVESTIGATION WAS REQUIRED BECAUSE THE FOLLOWING THRESHOLD WAS MET 3 OR MORE COMPLAINTS EXIST FOR THE SAME LOT AND SIMILAR MALFUNCTIONS. STATISTICAL ANALYSIS RESULT: AFTER ASSESSMENT OF THE FAILURE VIA PRODUCT TRENDING OVER TIME WITH CONTROL CHARTS, THE RISK HAS BEEN DEEMED AS WITHIN ACCEPTED LIMITS. NO FURTHER ACTION IS REQUIRED. SEE ATTACHMENT: FORM (1001680) SIGNED. COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE REPORT FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT. 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 6013783 AND RELATED MALFUNCTION CODES FOR ADHESIVE PATCH COMPLETELY DETACHES DURING USE-DETACHMENT / SIGNIFICANT WETNESS. MORE THAN 3 COMPLAINTS WERE IDENTIFIED FOR THIS LOT AND BASED ON THE ASSESSMENT OF THE MALFUNCTION AND PRODUCT FAMILY TRENDING OVER TIME, THE RISK HAS BEEN DEEMED WITHIN ACCEPTED LEVEL. THE MANUFACTURING RECORDS CONFIRMED THAT THE LOT WAS PRODUCED IN COMPLIANCE WITH ALL REQUIREMENTS, WITH NO DEVIATIONS OR MAINTENANCE EVENTS NOTED. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED, AND NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING. COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT.

    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) 2025. THE INFUSION SET WAS IN USE FOR 40 HOURS. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36452 INSET UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001680 6013783 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female