BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED QUICK-SET

    MDR report key: 19593728 · Received June 24, 2024

    Report

    Report Number
    3003442380-2024-10002
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    February 1, 2024
    Report Date
    July 29, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K160648
    Adverse Event
    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: A COMPLAINT INVESTIGATION HAS BEEN INITIATED FOR RECORD (B)(4) ON 28-JUL-2025. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002861 WAS MANUFACTURED ACCORDING TO THE WI VERSION 77 ON 28-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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 28/JUL/2025 AGAINST MALFUNCTION CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION, HARM CODE UNTREATED DIABETIC KETOACIDOSIS WHICH THE PATIENT IS UNABLE TO SELF MANAGE REQUIRING INTERVENTION BY A HEALTH CARE PROVIDER (HCP) OR REQUIRES EMERGENCY ADVANCE AND LOT 6007594 AND ANOTHER 17 COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER 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.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 01-FEBRUARY-2024, IT WAS REPORTED BY THE PATIENT THAT HE WAS HOSPITALIZED FOR EIGHT DAYS DUE TO HIGH BLOOD GLUCOSE AND KETONES. TREATMENT IS DONE BY HOSPITALIZATION TREATMENT. BLOOD GLUCOSE LEVEL AT THE TIME OF HOSPITALIZATION WAS 500 MG/DL AND CURRENT LEVEL WAS 252 MG/DL. 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
    1578082 MINIMED QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL A/S MMT-397A 6002861 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Congenital Anomaly| S