BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED SURE-T

    MDR report key: 21617209 · Received March 17, 2025

    Report

    Report Number
    3003442380-2025-03763
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    February 11, 2025
    Report Date
    July 1, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244019348
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES. INITIAL AND FINAL MDR (B)(4)-DEVICE 1 OF 2.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR 2140475 - MDR 3003442380-2025-03763. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE 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. THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH (B)(4) IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE TUBING CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE). PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1: STATIC PULL BASE-CONNECTOR ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2: CLICK ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6009739 WAS MANUFACTURED ACCORDING TO THE WI VERSION 98 AND PACKAGING IN THE MACHINE 14, ON 25 OCT 2024, WITH A TOTAL OF (B)(4) UNITS. WELDING: THE LOT 4K02950 WAS ASSEMBLED ACCORDING TO THE WI VERSION 34 ON-LINE INSPECTION FOR WELDING MACHINE LS07 AND LS06 ON 21 OCT 2024, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 4K02940 WAS ASSEMBLED ACCORDING TO THE WI VERSION 34 ON-LINE INSPECTION FOR WELDING MACHINE LS07 AND LS06 ON 06 NOV 2024, WITH A TOTAL OF (B)(4) UNITS EACH. GLUING OF CONNECTOR: THE LOT 4K01140 WAS GLUED ACCORDING TO THE WI VERSION 37, LINE 03 ON 18 OCT 2024, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 4K1141 WAS GLUED ACCORDING TO THE WI VERSION 37, LINE 3 AND 05 ON 19 OCT 2024, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 4K01142 WAS GLUED ACCORDING TO THE WI VERSION 37, LINE 03 AND 05 ON 20 OCT 2024, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 4K02882 WAS GLUED ACCORDING TO THE WI VERSION 37, LINE 3ON 20 OCT 2024, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 4K02898 WAS GLUED ACCORDING TO THE WI VERSION 37, LINE 3 ON 01 NOV 2024, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 4K02899 WAS GLUED ACCORDING TO THE WI VERSION 37, LINE 3 ON 01 NOV 2024, WITH A TOTAL OF (B)(4) UNITS EACH. 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; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 01 JUL 2025 AGAINST MALFUNCTION CODE TUBING CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE) AND LOT 6009739 AND NO MORE COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, 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 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 EVENTS ON (B)(6) 2025 AND (B)(6) 2025. THE TUBING CAME APART AT SITE. THE PUMP WAS NEAR THE SITE AND INFUSION SET WAS USED FOR TWELVE HOURS. 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
    1565451 MINIMED SURE-T UNO CONTACT DETACH G29 80/6 SC1 MIMX FPA UNOMEDICAL UM-D MMT-866A 6009739 05705244019348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown