BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21064615 · Received January 3, 2025

    Report

    Report Number
    3003442380-2024-35593
    Event Type
    Injury
    Date Received
    January 3, 2025
    Date of Event
    November 29, 2024
    Report Date
    May 13, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244017931
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    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: 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. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED FOR RECORD PR 2083680 ON 12-MAY-2025. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6009055 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 81 ON 11-SEP-2024, (B)(4). 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 12-MAY-2025 AGAINST HARM CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION, MALFUNCTION CODE NO MALFUNCTION DESCRIBE AND LOT 6009055 AND NO MORE COMPLAINT 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 CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES. ROOT CAUSE OF PROBLEM: N/A - THIS COMPLAINT DID NOT REQUIRE ESCALATION TO CAPA; THEREFORE, NO FURTHER ROOT CAUSE INVESTIGATION HAS BEEN COMPLETED. CORRECTIVE ACTION AS A RESULT OF THE INVESTIGATION: N/A - THIS COMPLAINT DID NOT REQUIRE ESCALATION TO CAPA, THEREFORE NO CAPA PLAN IS AVAILABLE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND THEN ADMITTED TO INTENSIVE CARE UNIT (ICU) ON (B)(6)2024 DUE TO DIABETIC KETOACIDOSIS EVENT. BLOOD GLUCOSE LEVEL WAS 423 MG/DL AT THE TIME OF THE EVENT. THE DURATION OF HOSPITALIZATION WAS GREATER THAN 24 HOURS. PATIENT EXPERIENCED THE SYMPTOMS OF TIRED. PATIENT WAS TREATED WITH INTRAVENOUS (IV) DRIP. NO FURTHER INFORMATION WAS 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
    431031 MINIMED QUICK-SET UNO QUICK-SET 110/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-398A 6009055 05705244017931

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H