BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINMED QUICK SET

    MDR report key: 19718542 · Received July 11, 2024

    Report

    Report Number
    3003442380-2024-13417
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 10, 2024
    Report Date
    August 26, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CITY: (B)(6).

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED DATE OF EVENT UNDER B3 AND 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) ACCORDING TO REFERENCE RESULTS COMPLAINT IS (B)(4) HAS BEEN EVALUATED. THE BATCH 6003957 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE MALFUNCTION CANNOT BE DETERMINED. THE BATCH 6003957 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 6003957 WAS MANUFACTURED ACCORDING TO THE DOCUMENT WORKING INSTRUCTION (WI) VERSION 77 ON THE PACKING PROCESS IN THE MACHINE 12, ON 24/OCT/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 06/AUG/2025 AGAINST MALFUNCTION CODE MALFUNCTION CANNOT BE DETERMINED, HARM CODE UNTREATED DIABETIC KETOACIDOSIS OR ISOLATED ELEVATED BLOOD GLUCOSE WHICH THE PATIENT IS UNABLE TO SELF-MANAGE REQUIRING INTERVENTION BY AN HEALTH CARE PROVIDER (HCP) OR REQUIRES EMERGENCY ADVANCED LIFE SUPPORT TO PREVENT PERMANENT ORGAN DAMAGE (ELEVATED BLOOD GLUCOSE LEVEL, PRESENCE OF KETONES AND SYMPTOMS E.G., NAUSEA, VOMITING, ABDOMINAL PAIN, CONFUSION) AND LOT 6003957 AND NO OTHER COMPLAINTS 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 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. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCK ALARM LEADING TO HIGH BLOOD GLUCOSE LEVEL OF 540 MG/DL. ASLO, THE PATIENT HAD BREATHING DIFFICULTY. THEREFORE, THE PATIENT WAS HSOPITALISED AND TREATED WITH INTRAVENOUS INSULIN DRIP. 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
    235806 MINMED QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL A/S MMT-397A 6003957 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H