BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 23013417 · Received September 10, 2025

    Report

    Report Number
    3003442380-2025-13527
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    August 4, 2025
    Report Date
    October 13, 2025
    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

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED BRAND NAME UNDER D1, 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: REVISION 21 OF (B)(4) DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6011830, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011830 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 AND MANUFACTURED IN THE LINE 7 ON 18-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, TUBE GLUING OF THE LOT 5A05771 WAS MANUFACTURED ACCORDING TO THE WI VERSION 66 AND MANUFACTURED IN THE MACHINE SC01, ON 25-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, TUBE GLUING OF THE LOT 5A06566 WAS MANUFACTURED ACCORDING TO THE WI VERSION 66 AND MANUFACTURED IN THE MACHINE SC04, ON 30-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, TUBE GLUING OF THE LOT 5B02458 WAS MANUFACTURED ACCORDING TO THE WI VERSION 2 AND MANUFACTURED IN THE MACHINE ITL03, ON 13-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT A NON-CONFORMANCES (NC) 2165520 WAS RAISED DURING THE STERILIZATION PROCESS. THIS NON-CONFORMANCE (NC) IS NOT RELATED TO CLAIMED MALFUNCTION. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: ONE NONCONFORMANCE NON-CONFORMANCE (NC) WAS RAISED DURING THE STERILIZATION PROCESS, AND FOUND UNRELATED TO THE REPORTED MALFUNCTION 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

    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 INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT WAS TREATED WITH CORRECTION BOLUS VIA PUMP. 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
    2488843 INSET UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001680 6011830 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male