BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 23421269 · Received October 30, 2025

    Report

    Report Number
    3003442380-2025-15505
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 3, 2025
    Report Date
    December 1, 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

    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 6013434 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DHR REVIEW: THE LOT 6013434 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND PACKAGING IN THE MULTIVAC M12 ON 19-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY LOT 5E03164 WAS MANUFACTURED ACCORDING TO THE WI VERSION 30 AND ASSEMBLED IN THE QUICKSET LINE, ON 18-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. LOT 5E03485 WAS MANUFACTURED ACCORDING TO THE WI VERSION 30 AND ASSEMBLED IN THE QUICKSET LINE, ON 19-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. LOT 5E03486 WAS MANUFACTURED ACCORDING TO THE WI VERSION 30 AND ASSEMBLED IN THE QUICKSET LINE, ON 19-MAY-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING THE LOT 5E01603 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE LINE MP04 , MP08 ON 17-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. 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.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: COLOMBIA.

    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 COLOMBIA. 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 ALMOST HALF OF THE DAY AFTER INSERTION. THE BLOOD GLUCOSE LEVEL WAS 400 MG/DL, AND THE PATIENT WAS TREATED WITH INSULIN INJECTION. THE PATIENT MOTHER STATED THAT THE BLOOD GLUCOSE STARTED RISING AND NOTICED THAT INFUSION SET TUBING WAS BROKEN AND NOTICED THAT INSULIN WAS DRIPPING OUT. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395404 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6013434 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown