BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21649952 · Received March 20, 2025

    Report

    Report Number
    3003442380-2025-04152
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    February 19, 2025
    Report Date
    September 12, 2025
    Manufacturer
    UNOMEDICAL UM-D
    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

    E1: PATIENT CITY - (B)(6). PATIENT COUNTRY - GERMANY.

    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: REVISION 21 OF (B)(4) DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6001902, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001902 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION VERSION 76 AND PACKAGING IN THE MULTIVAC M12 ON 19-JUN-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY OF THE LOT 3F02443 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 ASSEMBLED IN THE QUICKSET LINE, ON 16-JUN-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY OF THE LOT 3F02447 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 ASSEMBLED IN THE QUICKSET LINE, ON 19-JUN-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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 GERMANY. IT WAS REPORTED THAT PATIENT EXPERIENCED AN EVENT OF INFUSION SET DETACHMENT ON (B)(6)2025. THE SITE OF DETACHMENT WAS CLOSE TO INSERTION SITE. THE INSERTION SITE WAS RIGHT ABDOMEN. THE INFUSION SET WAS IN USE FOR ONE DAY. 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
    1177337 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A 6001902 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown