BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 24386454 · Received February 19, 2026

    Report

    Report Number
    3003442380-2026-00666
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    August 18, 2024
    Report Date
    February 2, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244016651
    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 IN RESPONSE TO THE WARNING LETTER CMS #(B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6000639, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON (B)(6) 2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL 6000639. THE COUNT OF COMPLAINT IS 0 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6000639 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 103 AND MANUFACTURED IN THE INSET LINE L175 ON 21-MAR-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TEST RESULTS: IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE(S) FROM THE LOT HAVE BEEN REQUESTED. NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED BY THE COMPLAINT. REFERENCE SAMPLES FROM THE SAME LOT WERE REQUESTED AND TESTED. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. WI GUIDANCE FOR FUNCTIONAL TESTING 1 FLOW TEST FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST WI GUIDANCE FOR FUNCTIONAL TESTING 2 LEAK TEST FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST THE FOLLOWING ADDITIONAL ACTIONS WERE TAKEN TO FURTHER SUPPORT THE INVESTIGATION: A REVIEW OF CURRENT CONTROLS FOR DHF-13 WAS CONDUCTED, A LIST OF EXISTING CONTROLS IN THE AUTOSOFT XC MANUFACTURING LINE IS BEING COMPILED TO DOCUMENT HOW LEAK FAILURES ARE CURRENTLY DETECTED AND PREVENTED AS DOCUMENTED IN THE MEMO TITLED "COSTUMER COMPLAINTS DATABASE (B)(6) CONTROLS IN THE PROCESS OF DHF 13" 1. 100% LEAK TEST IN FINAL ASSEMBLY PERFORMED USING TWO LEAK TESTER MACHINES. FOLLOWS DOCUMENT (B)(6) REV. 108. PFMECA 4906028 (INSET LINE 6) INDICATES SEVERITY 5 AND OCCURRENCE 1, MEANING THE RISK IS REMOTE AND ACCEPTABLE. 2. LEAK TEST IN WATER - SAMPLING PLAN CONDUCTED BEFORE PRODUCT RELEASE USING AQL 0.65%, PER DOCUMENT 4902110 REV. 14. RESULTS DOCUMENTED IN MULTIPLE INSPECTION RECORDS. PFMECA 4906008 (INSET PACKAGING) ALSO SHOWS SEVERITY 5 AND OCCURRENCE 1, CONFIRMING THE RISK IS REMOTE. PERSONNEL NOTIFICATION AND TRAINING: ALL OPERATORS INVOLVED IN THE MANUFACTURING OF AUTOSOFT XC WERE NOTIFIED OF THE ISSUE. A DOCUMENTED TRAINING SESSION WAS CONDUCTED TO REINFORCE AWARENESS OF THE FAILURE MODE AND PROPER HANDLING PROCEDURES. TRAINING SESSIONS WERE CARRIED OUT ACROSS ALL SHIFTS, FOCUSING ON THE POTENTIAL FAILURE MODE, CORRECT HANDLING PROCEDURES, AND THE CRITICAL ROLE OF VISUAL AND FUNCTIONAL INSPECTIONS. THESE SESSIONS SERVED AS A REMINDER TO REMAIN VIGILANT AND MAINTAIN HIGH STANDARDS IN DAILY OPERATIONS. THIS EFFORT HELPED ENSURE THAT EVERYONE INVOLVED CONTINUES TO FOLLOW ESTABLISHED CONTROLS AND REMAINS ATTENTIVE TO ANY SIGNS OF DEVIATION, EVEN IN CASES WHERE PRODUCT TRACEABILITY IS LIMITED. A CAPA DETERMINATION ASSESSMENT USING STATISTICAL ANALYSIS WAS CONDUCTED. CONCLUSION: THE INVESTIGATION FOR COMPLAINT CHILD RECORD(B)(6) FOUND NO PRODUCT OR PROCESS-RELATED ISSUES WITH BATCH 6000639. NO SIMILAR COMPLAINTS WERE IDENTIFIED, THE DHR MET ALL REQUIREMENTS, AND REFERENCE SAMPLES PASSED ALL VISUAL AND FUNCTIONAL TESTS. ALTHOUGH NOT REQUIRED, ADDITIONAL REVIEWS OF PROCESS CONTROLS AND PERSONNEL TRAINING WERE CONDUCTED, CONFIRMING THAT CURRENT CONTROLS ARE EFFECTIVE AND RISKS REMAIN LOW. A CAPA WAS ASSESSED AND DEEMED UNNECESSARY BASED ON THE INVESTIGATION RESULTS. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION PREVIOUSLY PERFORMED ON (B)(6) 2025: THE INVESTIGATION FOR THIS COMPLAINT WAS PREVIOUSLY COMPLETED UNDER CHILD COMPLAINT RECORD (B)(4). THE FOLLOWING SUMMARY REFLECTS THE RESULTS OF THAT PRIOR INVESTIGATION. A COMPREHENSIVE INVESTIGATION WAS PERFORMED, INCLUDING EQMS QUERIES, SEARCHES FOR SIMILAR COMPLAINTS, AND A COMPLETE DEVICE HISTORY RECORD (DHR) REVIEW. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE IDENTIFIED FOR LOT 6000639 OR THE ASSOCIATED MALFUNCTION CODES. THE DHR CONFIRMED THAT THE LOT MET ALL MANUFACTURING AND INSPECTION REQUIREMENTS WITH NO DEVIATIONS. NO SAMPLE WAS PROVIDED FOR ANALYSIS; THEREFORE, REFERENCE SAMPLES FROM THE SAME LOT WERE TESTED, AND ALL VISUAL, FLOW, AND LEAK TESTS MET SPECIFICATIONS WITH NO FAILURES OBSERVED. A REVIEW OF DHF 13 CONTROLS ALSO CONFIRMED THAT LEAK RELATED RISKS ARE EFFECTIVELY MITIGATED THROUGH 100% LEAK TESTING DURING FINAL ASSEMBLY AND AQL LEAK TESTING PRIOR TO RELEASE, WITH PFMECA RATINGS INDICATING A LOW, ACCEPTABLE RISK. ADDITIONALLY, ALL RELEVANT PERSONNEL WERE NOTIFIED AND PROVIDED REFRESHER TRAINING TO REINFORCE PROPER HANDLING AND INSPECTION PRACTICES. AS THE INVESTIGATION DID NOT IDENTIFY PRODUCT OR PROCESS ISSUES AND NO ESCALATION TO CAPA WAS REQUIRED, NO FURTHER ROOT CAUSE ANALYSIS OR CORRECTIVE ACTION PLAN WAS DEVELOPED. FOR ADDITIONAL DETAILS, REFER TO CHILD INVESTIGATION RECORD (B)(6).

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE INFUSION SET TUBING WAS LEAKING AT THE SITE EVENT OCCURED ON (B)(6) 2024. THE PATIENT EXPERIENCED THE REDNESS AT INFUSION SET INSERTION SITE. THE INFUSION SET WAS IN USE FOR THREE HOURS.THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448530 INSET UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001681 6000639 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male