BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21554914 · Received March 8, 2025

    Report

    Report Number
    3003442380-2025-03137
    Event Type
    Injury
    Date Received
    March 8, 2025
    Date of Event
    February 4, 2025
    Report Date
    May 5, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244017573
    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 (B)(4) ON 16-APR-2025. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002837 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 ON 27-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 16-APR-2025 AGAINST HARM CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION, MALFUNCTION CODE NO MALFUNCTION DESCRIBE AND LOT 6002837 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 EXPERIENCED HIGH BLOOD GLUCOSE LEVELS ON (B)(6) 2025. IT WAS ALSO REPORTED THAT THE PATIENT WENT TO EMERGENCY ROOM (ER) AND ADMITTED TO HOSPITAL ON (B)(6) 2025 AND RECEIVED INTRAVENOUS (IV) FLUIDS WITH INSULIN SALINE AND THE PATIENT BLOOD GLUCOSE LEVELS WHILE ADMITTING THE HOSPITAL WAS 300 MG/DL. THE PATIENT HAD SYMPTOMS OF CONFUSION, FEELING SICK/UNWELL, INCREASED THIRST, VOMITING, ABDOMINAL AND CHEST PAIN AND THE MAIN REASON FOR HOSPITALIZATION WAS HIGH BLOOD GLUCOSE LEVELS. 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
    906324 MINIMED QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL UM-D MMT-397A 6002837 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention