BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED SURE-T

    MDR report key: 22539187 · Received July 18, 2025

    Report

    Report Number
    3003442380-2025-11693
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    July 3, 2025
    Report Date
    October 15, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244019409
    PMA / PMN Number
    K160648
    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 - REVISION (B)(4) 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 6012679, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012679 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 101 AND MANUFACTURED IN THE MACHINE MULTIVAC 14 ON 05/APR/2025, WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT: THE LOT 5C04330 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE FT02 ON 31/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5C04332 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE FT02 ON 04/APR/2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT A NON-CONFORMANCE (NC) WAS OPENED DURING THE STERILIZATION PROCESSES ACTIONS WERE REQUIRED. THEREFORE, 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: ONE NC RAISED DURING STERILIZATION PROCESS UNRELATED TO COMPLAINT CODE, THEREFORE, NO 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 INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025 THE BLOCKAGE WAS IN THE TUBING. THE PATIENT REPLACED THE INFUSION SET 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
    350460 MINIMED SURE-T UNO CONTACT DETACH G29 80/8 SC1 MIMX FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-876A 6012679 05705244019409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown