BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED SURE-T

    MDR report key: 22058674 · Received May 21, 2025

    Report

    Report Number
    3003442380-2025-09349
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    April 29, 2025
    Report Date
    May 26, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244019317
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: HONG KONG.

    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 THE REFERENCE SAMPLES FOR THE LOT 6002554 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE 1952031 ON 11-FEB- 2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR CLICK AND STATIC PULL. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT 1952031. DEVICE HISTORY RECORD (DHR) REVIEW: THE 6002554 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 94 PACKAGED IN THE MV10, ON 07/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. WELDING: THE LOT 3G05443 WAS ASSEMBLED ACCORDING TO THE WI VERSION 32, L525 ON 06-AUG-2024, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 3G05419 WAS ASSEMBLED ACCORDING TO THE WI VERSION 32, L524 ON 06-AUG-2024, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 3G05881 WAS ASSEMBLED ACCORDING TO THE WI VERSION 32, L525 ON 09-AUG-2023, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 3H00512 WAS ASSEMBLED ACCORDING TO THE WI VERSION 32, L524 ON 07-AUG-2023, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 3G05447 WAS ASSEMBLED ACCORDING TO THE WI VERSION 32, L525 ON 07-AUG-2023, WITH A TOTAL OF (B)(4) UNITS EACH. GLUING OF TUBING: THE LOT 3H01439 WAS GLUED ACCORDING TO THE WI VERSION 55, MACHINE SC05, ON 20/AUG/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H00666 WAS GLUED ACCORDING TO THE WI VERSION 55, MACHINE SC05, ON 13/AUG/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H00665 WAS GLUED ACCORDING TO THE WI VERSION 55, MACHINE SPOT 06, ON 13/AUG/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3G0489 2WAS GLUED ACCORDING TO THE WI VERSION 55, MACHINE SC05, ON 06/AUG/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 WERE IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 21/MAY/2025 AGAINST MALFUNCTION CODE TUBING CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE) AND LOT 6002554 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6002554 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: HARM REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE PMS PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR).

    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. THE REFERENCE SAMPLES FOR THE LOT 6002554 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE 1952031 ON 11-FEB- 2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR CLICK AND STATIC PULL. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT 1952031. DEVICE HISTORY RECORD (DHR) REVIEW: THE 6002554 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 94 PACKAGED IN THE MV10, ON 07/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. WELDING: THE LOT 3G05443 WAS ASSEMBLED ACCORDING TO THE WI VERSION 32, L525 ON 06-AUG-2024, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 3G05419 WAS ASSEMBLED ACCORDING TO THE WI VERSION 32, L524 ON 06-AUG-2024, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 3G05881 WAS ASSEMBLED ACCORDING TO THE WI VERSION 32, L525 ON 09-AUG-2023, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 3H00512 WAS ASSEMBLED ACCORDING TO THE WI VERSION 32, L524 ON 07-AUG-2023, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 3G05447 WAS ASSEMBLED ACCORDING TO THE WI VERSION 32, L525 ON 07-AUG-2023, WITH A TOTAL OF (B)(4) UNITS EACH. GLUING OF TUBING: THE LOT 3H01439 WAS GLUED ACCORDING TO THE WI VERSION 55, MACHINE SC05, ON 20/AUG/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H00666 WAS GLUED ACCORDING TO THE WI VERSION 55, MACHINE SC05, ON 13/AUG/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H00665 WAS GLUED ACCORDING TO THE WI VERSION 55, MACHINE SPOT 06, ON 13/AUG/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3G0489 2WAS GLUED ACCORDING TO THE WI VERSION 55, MACHINE SC05, ON 06/AUG/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 WERE IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 21/MAY/2025 AGAINST MALFUNCTION CODE TUBING CONNECTOR DETACHED FROM INFUSION SET AND LOT 6002554 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6002554 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: HARM REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKETING SURVILLENCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR) PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN HONG KONG. IT WAS REPORTED THAT THE PATIENT EXPERIENCED THAT INFUSION SET TUBING WAS DETACHED WHICH OCCURRED ON (B)(6) 2025. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    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
    645041 MINIMED SURE-T UNO CONTACT DETACH G29 60/6 SC1 MIMX FPA UNOMEDICAL UM-D MMT-864A 6002554 05705244019317

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown