BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 20999643 · Received December 23, 2024

    Report

    Report Number
    3003442380-2024-35115
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    November 22, 2024
    Report Date
    February 20, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    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: THE REFERENCE SAMPLES FOR THE LOT 6003969 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE (B)(4) ON 28-APR- 2024. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT.. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003969 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 MANUFACTURED IN THE MACHINE 12, ON 31/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING THE LOT 3K03770 WAS GLUED ACCORDING TO THE WI VERSION 26, MACHINE SC01, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3K03772 WAS GLUED ACCORDING TO THE WI VERSION 26, MACHINE SC01, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3K04922 WAS GLUED ACCORDING TO THE WI VERSION 26, MACHINE SC01, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3K04924 WAS GLUED ACCORDING TO THE WI VERSION 26, MACHINE SC01, 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 WERE IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 19-FEB-2025 AGAINST MALFUNCTION CODE OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G., OCCLUSION ALARM FROM THE INFUSION PUMPMAY HAVE SOUNDED) AND LOT 6003969 NO MORE COMPLAINTS HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6003969 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: HARM NO REPORTABLE, NO DEFECT ON TESTS FOR RETENTION SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION. NO FURTHER ACTIONS ARE REQUIRED. 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 THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2024. THE BLOCKAGE WAS IN THE TUBING. 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
    2629367 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A 6003969

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown