BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINMED QUICK SET

    MDR report key: 19495013 · Received June 8, 2024

    Report

    Report Number
    3003442380-2024-07291
    Event Type
    Injury
    Date Received
    June 8, 2024
    Date of Event
    May 9, 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)

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4. 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 6002836 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 6002836 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 PACKAGING, ON 25/AGO/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 SIGNS OF UNTREATED HYPOGLYCAEMIA THAT 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 AND LOT 6002836 AND NO OTHER COMPLAINT HAS 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, 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.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT PASSED OUT WHILE GETTING READY FOR BED. THE BLOOD GLUCOSE WAS 40MG/DL. THE PATIENT DRANK COKE AS TO TREAT HYPOGLYCEMIA. THE PATIENT WENT TO THE EMERGENCY ROOM BUT WAS NOT HOSPITALIZED AS HER BLOOD GLUCOSE WAS GOING UP. NO FURTHER INFORMATION 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
    2325995 MINMED QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL A/S MMT-397A 6002836 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention