BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED SURE-T

    MDR report key: 21760280 · Received April 3, 2025

    Report

    Report Number
    3003442380-2025-05227
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 4, 2025
    Report Date
    September 5, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V
    Product Code
    FPA
    UDI-DI
    05705244019409
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES.

    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 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 6003864, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003864 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 94 AND PACKAGED THE MULTIVAC M10 ON 20/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING: LOT 3J01354 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND MANUFACTURED IN THE MACHINE FT02, ON 19/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3K02552 WAS MANUFACTURED ACCORDING TO THE WI VERSION 56 AND MANUFACTURED IN THE MACHINE FT20, ON 17/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3J02151 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND MANUFACTURED IN THE MACHINE FT02, ON 14/SEP/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. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND 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

    REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED STATES. ON (B)(6) 2025, THE PATIENT ENCOUNTERED AN INSULIN FLOW BLOCKAGE EVENT. OBSTRUCTION OCCURRED WITHIN THE TUBING. 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
    1444324 MINIMED SURE-T UNO CONTACT DETACH G29 80/8 SC1 MIMX FPA UNOMEDICAL DEVICES S.A. DE C.V MMT-876A 6003864 05705244019409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown