BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED QUICK-SET

    MDR report key: 20512987 · Received October 23, 2024

    Report

    Report Number
    3003442380-2024-28844
    Event Type
    Injury
    Date Received
    October 23, 2024
    Date of Event
    September 12, 2024
    Report Date
    August 1, 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

    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: COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED FOR RECORD COMPLAINT (B)(4) ON 31-JUL-2025. COMPLAINT INVESTIGATION: THE REFERENCE SAMPLES CANNOT BE TESTED BECAUSE THERE WAS NO SPECIFIC MALFUNCTION TO INVESTIGATE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003552 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 MANUFACTURED IN THE MACHINE 12, ON 30/SEP/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, NOR MAINTENANCE EVENTS WERE RECORDED TRENDING: A QUERY WAS RUN IN DATABASE ON 31-JUL-2025 AGAINST HARM CODE UNTREATED DIABETIC KETOACIDOSIS WHICH THE PATIENT IS UNABLE TO SELF-MANAGE REQUIRING INTERVENTION BY A HEALTH CARE PROFESSIONAL (HCP) OR REQUIRES EMERGENCY ADVANCE , MALFUNCTION CODE NO MALFUNCTION DESCRIBES AND LOT 6003552 AND ONE 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, ONE MORE 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 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: EGYPT.

    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 EGYPT, IT WAS REPORTED THAT ON (B)(6) 2024 PATIENT VISIT TO EMERGENCY ROOM AND THE BLOOD GLUCOSE VALUE IS 346 MG/DL DUE TO MANUAL INJECTION. THE LENGTH OF HOSPITALIZATION IS LESS THAN 24 HOURS AND REASON OF HOSPITALIZATION IS PATIENT JUST VISIT EMERGENCY ROOM. THE SYMPTOMS PATIENT FACES AT THE TIME OF HOSPITALIZATION IS NAUSEA, VOMITING AND STOMACHACHE AND PATIENT ALSO HAVE KETONES. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36350 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6003552 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R