BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 22870133 · Received August 22, 2025

    Report

    Report Number
    3003442380-2025-13124
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    August 2, 2025
    Report Date
    September 25, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244016682
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) DEVICE 2 OF 2.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 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 PER REVISION 21 OF PROCEDURE (B)(4), A CHILD INVESTIGATION IS NOT REQUIRED TO DOCUMENT THE DEVICE HISTORY RECORD (DHR) REVIEW FOR A TYPE 2 REPORTABLE COMPLAINT. HOWEVER, THE CHILD WAS CREATED TO ALLOW THE PARENT RECORD TO ADVANCE TO REVIEW AND SUMMARY. SINCE IT WAS CREATED, THE DHR REVIEW WAS DOCUMENTED WITHIN THE CHILD. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4) THE BATCH 6011404, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DHR REVIEW: THE LOT 6011404 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 AND MANUFACTURED IN THE LINE INSET 4 ON 30-JAN-2025, 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. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES. .

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED TWO INFUSION SETS EVENTS WHERE INSULIN WAS NOT PASSING THROUGH THE CANNULA ON (B)(6) 2025. THE EVENTS OCCURRED THREE OR MORE HOURS AFTER INSERTION. THE INFUSION SETS WERE IN USE FOR LESS THAN 24 HOURS. THE INSERTION SITES WERE ABDOMEN AND UPPER BUTTOCKS. PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661334 INSET UNO INSET I 60/6 PINK TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001682 6011404 05705244016682

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female