BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 23289555 · Received October 15, 2025

    Report

    Report Number
    3003442380-2025-14891
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 15, 2025
    Report Date
    December 2, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES.

    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. H11: INVESTIGATION SUMMARY. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED TO REVIEW THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH THE REPORTED ISSUE. THE BATCH 6013446, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DHR REVIEW: THE LOT 6013446 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82.0, IN THE MULTIVAC 12, ON 22/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY THE LOT 5E03505 WAS MANUFACTURED ACCORDING TO THE WI VERSION 30.0 AND ASSEMBLED IN THE QUICKSET LINE, ON 22/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E03506 WAS MANUFACTURED ACCORDING TO THE WI VERSION 30.0 AND ASSEMBLED IN THE QUICKSET LINE, ON 23/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING THE LOT 5E03431 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42.0 AND MANUFACTURED IN THE LINE MP04-MP08, ON 22/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E03422 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42.0 AND MANUFACTURED IN THE LINE MP04-MP08, ON 21/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E01608 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42.0 AND MANUFACTURED IN THE LINE MP04-MP05, ON 18/MAY/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 RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT EXPERIENCED AN EVENT OF TUBING GOT KINKED ON (B)(6) 2025. THE PATIENT HAD HIGH BLOOD GLUCOSE WHEN SHE WOKE UP IN THE MORNING. THE PATIENT HAD A CORRECTION BOLUS AND TAKEN CARBS FOR HER BREAKFAST AND COMPLETE SET WAS CHANGED AS A TREATMENT. 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
    259485 QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL A/S MMT-397A 6013446 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female