BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED QUICK-SET

    MDR report key: 22112233 · Received May 30, 2025

    Report

    Report Number
    3003442380-2025-10150
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    March 17, 2025
    Report Date
    July 9, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    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: THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION. THE BATCH 6010034 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATION: THE REFERENCE SAMPLES CANNOT BE TESTED BECAUSE THERE WAS NO SPECIFIC MALFUNCTION TO INVESTIGATE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010034 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82, PACKAGED IN THE MACHINE M 12, ON 29/OCT/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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 08/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 AN HEALTH CARE PROFESSIONAL (HCP) OR REQUIRES EMERGENCY ADVANCED LIFE SUPPORT TO PREVENT PERMANENT ORGAN DAMAGE (ELEVATED BLOOD GLUCOSE LEVEL AND SYMPTOMS E.G., MODERATE TO LARGE KETONES, NAUSEA, VOMITING, ABDOMINAL PAIN, CONFUSION) AND LOT 6010034 AND NO OTHER COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER, HARM CODE AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION, HARM CODE AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION OR CAPA PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6), PATIENT COUNTRY: UNITED STATES.

    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 THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WENT TO EMERGENCY ROOM AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2025 DUE TO DIABETIC KETOACIDOSIS (DKA) AND HYPERGLYCEMIC EVENT. BLOOD GLUCOSE LEVEL WAS OVER 758 MG/DL AT THE TIME OF THE EVENT. THE DURATION OF HOSPITALIZATION WAS GREATER THAN 24 HOURS. PATIENT GOT TREATED WITH INTRAVENOUS (IV) FLUIDS. PATIENT WAS EXPERIENCED THE SYMPTOMS OF HEADACHE, TIRED/WEAK AND DEHYDRATION. PATIENT WAS FOUND POSITIVE FOR HIGH KETONES LEVEL. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578954 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6010034 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R