BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK-SET

    MDR report key: 22724953 · Received August 6, 2025

    Report

    Report Number
    3003442380-2025-12449
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    July 11, 2025
    Report Date
    July 23, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K991759
    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. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED FOR RECORD (B)(4) ON 23-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 6011504 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 ON 03-FEB-2025, 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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED TRENDING: A QUERY WAS RUN IN DATABASE ON 23-JUL-2025 AGAINST HARM CODE SIGNS OF UNTREATED HYPOGLYCEMIA THAT PATIENT IS UNABLE TO SELF-MANAGE REQUIRING INTERVENTION BY A HEALTH CARE PROFESSIONAL (HCP) OR REQUIRES EMERGENCY ADVANCED LIFE, MALFUNCTION CODE NO MALFUNCTION DESCRIBE AND LOT 6011504 AND NO 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, 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 - UNITED STATES. 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 (B)(6) 2025. COMPLAINT INVESTIGATION: THE REFERENCE SAMPLES CANNOT BE TESTED BECAUSE THERE WAS NO SPECIFIC MALFUNCTION TO INVESTIGATE. SEE ATTACHMENT COMPLAINT (B)(4) COMPLAINT TEST REPORT.PDF FOR THE DETAILS. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011504 WAS MANUFACTURED ACCORDING TO THE[?]WORK INSTRUCTION (WI) VERSION 82 ON (B)(6) 2025, 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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED TRENDING: A QUERY WAS RUN IN DATABASE ON (B)(6) 2025 AGAINST HARM CODE SIGNS OF UNTREATED HYPOGLYCEMIA THAT PATIENT IS UNABLE TO SELF-MANAGE REQUIRING INTERVENTION BY A HEALTH CARE PROVIDER (HCP) OR REQUIRES EMERGENCY ADVANCED LIFE, MALFUNCTION CODE NO MALFUNCTION DESCRIBE AND LOT 6011504 AND NO 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, 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.

    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 EXPERIENCED LOW BLOOD GLUCOSE LEVELS AND LATER GOT AMBULATORY ASSISTANCE FOR THE TREATMENT ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL WAS 48 MG/DL AT THE TIME OF EVENT. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337203 QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A 6011504 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown