BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 24108499 · Received January 19, 2026

    Report

    Report Number
    3003442380-2025-14084
    Event Type
    Injury
    Date Received
    January 19, 2026
    Date of Event
    December 22, 2025
    Report Date
    February 13, 2026
    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

    INITIAL AND FINAL MDR-(B)(4) DEVICE 2 OF 3. E1: PATIENT CITY: (B)(6) PATIENT COUNTRY: SPAIN.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01- MDR (B)(4). 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: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 04-FEB-2026 AGAINST "LOT NUMBER 6013276 AND SIMILAR MALFUNCTION CODES: NON PRODUCT RELATED EVENT DUE TO PRIOR CLINICAL CIRCUMSTANCES, IMPROPER PRODUCT SELECTION/TREATMENT METHOD, ACCORDING TO CLINICAL HISTORY OF THE COSTUMER (E.G., HISTORY OF ALLERGIC REACTIONS, CONTINUING USE DESPITE KNOWN ISSUES WHEN USING THE SET), CLINICAL HISTORY - NON-PRODUCT EVENT, THE REVIEW CONFIRMED THAT LOT 6013276 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 04-FEB-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6013276 AND SIMILAR MALFUNCTION CODES NON PRODUCT RELATED EVENT DUE TO PRIOR CLINICAL CIRCUMSTANCES, IMPROPER PRODUCT SELECTION/TREATMENT METHOD, ACCORDING TO CLINICAL HISTORY OF THE COSTUMER (E.G., HISTORY OF ALLERGIC REACTIONS, CONTINUING USE DESPITE KNOWN ISSUES WHEN USING THE SET), CLINICAL HISTORY - NON-PRODUCT EVENT. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBERS ARE COMPLAINT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011110 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND PACKAGED IN THE MACHINE MULTIVAC 12, ON 16-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED IN ACCORDANCE WITH APPLICABLE PROCEDURES. ALL REQUIRED IN-PROCESS AND FINAL TESTS WERE COMPLETED AND MET SPECIFIED REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED THAT RELATE TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS; NO ISSUES NOTED. VISUAL EVIDENCE REVIEW: NO PHOTO WAS PROVIDED TO SUPPORT VISUAL CONFIRMATION OF THE REPORTED ISSUE. CONCLUSION: UNABLE TO PERFORM VISUAL VERIFICATION; ASSESSMENT BASED ON AVAILABLE DOCUMENTATION ONLY. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI (MONTHLY TRIPS AND ALERTS). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION AS A RESULT OF THE FOLLOWING: A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING EQMS QUERIES, SIMILAR COMPLAINT SEARCHES, DEVICE HISTORY RECORD REVIEW, VISUAL EVIDENCE ASSESSMENT, AND CAPA DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6013276 AND RELATED MALFUNCTION CODES. ONE COMPLAINT WAS IDENTIFIED FOR THIS LOT; HOWEVER, NO TREND OR SYSTEMIC ISSUE WAS DETECTED. THE MANUFACTURING RECORDS CONFIRMED THAT THE LOT WAS PRODUCED IN COMPLIANCE WITH ALL REQUIREMENTS, WITH NO DEVIATIONS OR MAINTENANCE EVENTS NOTED. NO RETAIN SAMPLES WERE REQUESTED AND NO PRODUCT TESTING WAS PERFORMED, BASED ON THE CLASSIFICATION OF THE MALFUNCTION CODE, THIS TYPE OF ISSUE DOES NOT REQUIRE VISUAL TESTING, FUNCTIONAL TESTING, OR EVALUATION OF RETAIN SAMPLES, AS IT CORRESPONDS TO CATEGORIES SUCH AS "MISUSE, USER RELATED ISSUES, OR NO MALFUNCTION ALLEGED. SO, THE ASSESSMENT WAS BASED ON DOCUMENTATION. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4) EVENT OCCURRED IN SPAIN. IT WAS REPORTED THAT THE PATIENT FACED THREE CONSECUTIVE BENT CANNULAS ISSUE ON (B)(6) 2025. THE PATIENT DID NOT HAVE SUFFICIENT SUBCUTANEOUS TISSUE WHERE INFUSION SET WAS INSERTED, THE PATIENT WAS VERY THIN WHICH LEADS TO HIGH BLOOD GLUCOSE LEVELS UPTO 460 MG/DL WITH HIGH KETONES BODIES. THE PATIENT USED INFUSION SET FOR FEW HOURS, AND THE SITE OF INSERTION WAS GLUTEUS. THE PATIENT WAS TREATED WITH INSULIN PEN. 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
    170111 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6013276 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention