BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED SILHOUETTE

    MDR report key: 22032771 · Received May 16, 2025

    Report

    Report Number
    3003442380-2025-09014
    Event Type
    Injury
    Date Received
    May 16, 2025
    Date of Event
    April 19, 2025
    Report Date
    July 11, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244019614
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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 FOR RECORD COMPLAINT (B)(4) ON 10-JUL-2025. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002924 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 15 ON 19-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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED TRENDING: A QUERY WAS RUN IN DATABASE ON 09-JUL-2025 AGAINST HARM CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION, MALFUNCTION CODE NO MALFUNCTION DESCRIBE AND LOT 6002924 AND 2 MORE COMPLAINTS HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT, HARM CODE AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ONLY ONE COMPLAINT RECEIVED ON THE LOT IN QUESTION AND HARM CODE, THE TEST ON REFERENCE SAMPLES WERE NOT TESTED SINCE A NO MALFUNCTION RELATED TO THE INFUSION SET WAS REPORTED, THEREFORE 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

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

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EVENT OF LOW BLOOD GLUCOSE (50 MG/DL) WHICH LED TO EMERGENCY ROOM VISIT ON (B)(6) 2025. PATIENT WAS TREATED INTRAVENOUSLY AT THE HOSPITAL. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215961 MINIMED SILHOUETTE UNO COMFORT SHORT 110/13 SC1 MINI FPA UNOMEDICAL A/S MMT-382A 6002924 05705244019614

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization