BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED SILHOUETTE

    MDR report key: 22455153 · Received July 9, 2025

    Report

    Report Number
    3003442380-2025-11401
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    June 20, 2025
    Report Date
    October 14, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244019584
    PMA / PMN Number
    K162812
    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: THE 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 3709030 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 3709030. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6010318, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010318 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 20 AND MANUFACTURED IN THE MACHINE MULTIVAC 14 ON 28/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. CANNULA LOT: THE LOT 4K02666 WAS MANUFACTURED ACCORDING TO THE WI VERSION 16 AND MANUFACTURED IN THE MACHINE LC05 ON 09/NOV/2024, 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 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). THE EVENT OCCURED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT ON 20-JUN-2025 THE BLOOD GLUCOSE LEVEL WAS 214 AND THE PATIENT WAS TREATED WITH CORRECTION BOLUS VIA PUMP.THE INFUSION SET WAS IN USE FOR 72HRS. THE PATIENT ALSO FACED BLEEDING AT THE INSERTION SITE. 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
    148388 MINIMED SILHOUETTE UNO COMFORT SHORT 60/13 SC1 MIN FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-381A 6010318 05705244019584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown