BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED SILHOUETTE

    MDR report key: 21729145 · Received March 31, 2025

    Report

    Report Number
    3003442380-2025-04997
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    March 2, 2025
    Report Date
    September 17, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244019584
    PMA / PMN Number
    K162812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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: COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6000945, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6000945 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 14 AND PACKAGING IN THE MULTIVAC M10 ON 06-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. AN EXTENDED FOR DELAMINATED TAPE WAS PERFORMED FOR THE OUTGOING TEST 9(G). THE SUB-ASSEMBLY: CANNULA OF THE LOT 3E00791 WAS MANUFACTURED ACCORDING TO THE WI VERSION 11 AND MANUFACTURED IN THE MACHINE LC05, ON 03-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: CANNULA OF THE LOT 3D01364 WAS MANUFACTURED ACCORDING TO THE WI VERSION 11 AND MANUFACTURED IN THE MACHINE LC05, ON 03-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: CANNULA OF THE LOT 3E01139 WAS MANUFACTURED ACCORDING TO THE WI VERSION 11 AND MANUFACTURED IN THE MACHINE LC05, ON 08-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: CANNULA OF THE LOT 3D01362 WAS MANUFACTURED ACCORDING TO THE WI VERSION 11 AND MANUFACTURED IN THE MACHINE LC04, ON 01-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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 OCCURRED IN THE KOREA, REPUBLIC OF. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EVENT OF NEEDLE BREAK ON (B)(6) 2025. THE SITE OF INSERTION WAS ABDOMEN. 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
    1009902 MINIMED SILHOUETTE UNO COMFORT SHORT 60/13 SC1 MIN FPA UNOMEDICAL UM-D MMT-381A 6000945 05705244019584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown