BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET PARADIGM

    MDR report key: 19446708 · Received June 3, 2024

    Report

    Report Number
    3003442380-2024-05778
    Event Type
    Injury
    Date Received
    June 3, 2024
    Date of Event
    April 20, 2024
    Report Date
    December 11, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - MDR 3003442380-2024-05778- DEVICE 1 OF 2. E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: BRAZIL.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR. THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER, WAS SUBMITTED ON 03-JUN-2024. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 28-OCT-2023. 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 10/DEC/2025 AGAINST "LOT NUMBER" "6003966" AND SIMILAR MALFUNCTION CODES: LEAKAGE FROM INFUSION SITE (SPECIFIC CAUSE NOT IDENTIFIED), INFUSION SITE LEAKAGE - TRACE MOISTURE / SUPERFICIAL WETNESS, LEAKAGE AT INFUSION SITE - SIGNIFICANT WETNESS /POOLING. THE REVIEW CONFIRMED THAT LOT 6003966 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CORRECTIVE AND PREVENTIVE ACTIONS (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH A QUERY WAS RUN IN THE EQMS ON 11/DEC/2025 AGAINST "LOT NUMBER" CRITERIA EQUAL "6003966" AND SIMILAR MALFUNCTION CODES: LEAKAGE FROM INFUSION SITE (SPECIFIC CAUSE NOT IDENTIFIED), INFUSION SITE LEAKAGE - TRACE MOISTURE / SUPERFICIAL WETNESS, LEAKAGE AT INFUSION SITE - SIGNIFICANT WETNESS /POOLING. THE COUNT OF COMPLAINTS IS 1. THE COMPLAINTS NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW THE LOT 6003966 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 AND PACKAGING IN THE MULTIVAC 12 ON 28/OCT/2023 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF THE LOT 3K03769 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE QUICKSET LINE, ON 29/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF THE LOT 3K03766 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE QUICKSET LINE, ON 29/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF THE LOT 3K03767 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE QUICKSET LINE, ON 29/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 3K02798 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE MACHINES MP04, MP05 & MP08, ON 27/OCT/2023, 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. CAPA DETERMINATION ASSESSMENT - 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 6003966 AND RELATED MALFUNCTION CODES. ONE COMPLAINT WAS IDENTIFIED FOR THIS LOT, BUT 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 PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED, AND NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING. FOR MORE DETAILS SEE THE INFORMATION UNDER THE CHILD INVESTIGATION RECORD (B)(4).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN BRAZIL. IT WAS REPORTED THAT PATIENT FACED 2 INFUSION SET LEAKAGE EVENTS ON (B)(6) 2024. THE BLOOD GLUCOSE LEVEL WAS HIGH AND HAD EXPERIENCED KETOACIDOSIS. THEREFORE, PATIENT WAS HOSPITALIZED. 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
    350639 QUICK SET PARADIGM UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6003966 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R