BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED SURE-T

    MDR report key: 22067769 · Received May 22, 2025

    Report

    Report Number
    3003442380-2025-09418
    Event Type
    Malfunction
    Date Received
    May 22, 2025
    Date of Event
    May 1, 2025
    Report Date
    June 25, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244019379
    PMA / PMN Number
    K160648
    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 MANUFACTURING DATE UNDER H4. 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. THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). THE BATCH (B)(4) IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATIONS. THE REFERENCE SAMPLES FOR BATCH (B)(4) WERE PREVIOUSLY TESTED IN COMPLAINT (B)(4) ON 21 JUNE 2025. TEST RESULTS: VISUAL TEST ACCORDING TO WORK INSTRUCTION (WI) VERSION 3.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WI VERSION 2.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING. THE LOT 6011047 WAS MANUFACTURED ACCORDING TO THE WI VERSION 99 AND PACKAGING IN THE MULTIVAC 14, ON 06 JANUARY 2025, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING. THE LOT 4M03028 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65 IN THE GLUING OF TUBING IN THE MACHINE SC05, ON 15 DECEMBER 2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4M03279 WAS MANUFACTURED ACCORDING TO THE WI VERSION 66 IN THE GLUING OF TUBING IN THE MACHINE SC05 & SC06, ON 03 JANUARY 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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 19 JUNE 2025 AGAINST MALFUNCTION CODE OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) AND LOT 6011047 AND ANOTHER 1 COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ANOTHER 1 COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE. NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR 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 01-MAY-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
    1070358 MINIMED SURE-T UNO CONTACT DETACH G29 60/8 SC1 MIMX FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-874A 6011047 05705244019379

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown