BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 23714141 · Received December 4, 2025

    Report

    Report Number
    3003442380-2025-17201
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 23, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2025-17201. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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 22-DEC-2025 AGAINST "LOT NUMBER 6003015 AND SIMILAR MALFUNCTION CODE(S): LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING), LEAK BETWEEN TUBING AND PUMP CONNECTOR/HUB - TRACE MOISTURE / MINOR WETNESS, LEAK BETWEEN TUBING AND PUMP CONNECTOR/HUB - DETACHMENT /SIGNIFICANT WETNESS. THE REVIEW CONFIRMED THAT LOT 6003015 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 22-DEC-2025 AGAINST "LOT NUMBER" CRITERIA EQUAL 6003015 AND SIMILAR MALFUNCTION CODES LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING), LEAK BETWEEN TUBING AND PUMP CONNECTOR/HUB - TRACE MOISTURE / MINOR WETNESS, LEAK BETWEEN TUBING AND PUMP CONNECTOR/HUB - DETACHMENT /SIGNIFICANT WETNESS. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003015 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 AND MANUFACTURED IN THE MULTIVAC M08 ON 06/SEP/2023 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, OF THE LOT 3H04063 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE QUICKSET LINE, ON 06/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, OF THE LOT 3J01641 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE QUICKSET LINE, ON 11/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF TUBING, OF THE LOT 3H04046 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE GLUING MACHINE 04, ON 30/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF TUBING, OF THE LOT 3H04056 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 AND MANUFACTURED IN THE GLUING MACHINE 05, ON 03/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF TUBING, OF THE LOT 3J00248 WAS MANUFACTURED ACCORDING TO THE WI VERSION 14 AND MANUFACTURED IN THE GLUING MACHINE 04, ON 08/SEP/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. 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 CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6003015 AND RELATED MALFUNCTION CODES FOR LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING). 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.

    Additional Manufacturer Narrative · 0

    E1:PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED ARAB EMIRATES.

    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 ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2025. THE LEAKAGE WAS IN THE TUBING. THE INFUSION SET WAS IN USE FOR TWO DAYS. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT WAS TREATED WITH MANUAL INJECTION. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1892108 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6003015 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown