BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK-SET

    MDR report key: 22746673 · Received August 8, 2025

    Report

    Report Number
    3003442380-2025-12564
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    July 20, 2025
    Report Date
    August 11, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K991759
    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 DATE OF EVENT UNDER B3. 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 6001937 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. TEST RESULTS: COMPLAINT INVESTIGATION: THE REFERENCE SAMPLES CANNOT BE TESTED BECAUSE THERE WAS NO SPECIFIC MALFUNCTION TO INVESTIGATE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001937 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 PACKAGING IN THE MULTIVAC12, ON29/JUN/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 11/AUG/2025 AGAINST HARM CODE UNTREATED DIABETIC KETOACIDOSIS WHICH THE PATIENT IS UNABLE TO SELF-MANAGE REQUIRING INTERVENTION BY A 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), MALFUNCTION CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION DESCRIBE AND LOT 6001937 AND NO OTHER 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, 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 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: CANADA.

    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 CANADA. IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2025 DUE TO HYPERGLYCEMIA EVENT. BLOOD GLUCOSE LEVEL WAS 32 MMOL/L AT THE TIME OF THE EVENT AND PATIENT GOT TREATED WITH INTRAVENOUS (IV) DRIP. PATIENT ALSO EXPERIENCED THE SYMPTOMS OF FEELING SICK AT THE TIME OF THE EVENT. PATIENT WAS FOUND POSITIVE FOR KETONES LEVEL. THE DURATION OF HOSPITALIZATION WAS 5 DAYS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220742 QUICK-SET UNO QUICK-SET 46/6 SC1 MCAN FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-394A600 6001937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R