BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21595436 · Received March 13, 2025

    Report

    Report Number
    3003442380-2025-03755
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    February 9, 2025
    Report Date
    May 6, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244018051
    PMA / PMN Number
    K160648
    Adverse Event
    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, COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED FOR RECORD COMPLAINT 2140780 ON 30-APR-2025. TEST RESULTS: VISUAL TEST ACCORDING TO WITH WI VERSION 77 ON 25-JUL-2023, WITH A TOTAL OF (B)(4) UNITS. FUNCTIONAL TEST STATIC PULL OF THE TUBING-TUBING CONNECTOR 1 ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002446 WAS MANUFACTURED ACCORDING TO THE WI VERSION 116 AND MANUFACTURED IN THE LINE 4, ON 06/SEP/2024, WITH A TOTAL OF (B)(4) UNITS.URED IN THE LINE 8, ON 02/MAY/2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 30-APR-2025 AGAINST MALFUNCTION CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION AND LOT 6002446 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6002446 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT. AS A RESULT OF THE FOLLOWING: NO REPORTED HARM, NO DEFECT ON TEST, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ONLY ONE COMPLAINT RECEIVED ON THE LOT IN QUESTION AND HARM CODE, THE TEST ON REFERENCE SAMPLES WERE NOT TESTED SINCE A NO MALFUNCTION RELATED TO THE INFUSION SET WAS REPORTED, THEREFORE NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CAPA PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES. ROOT CAUSE OF PROBLEM: N/A - THIS COMPLAINT DID NOT REQUIRE ESCALATION TO CAPA; THEREFORE, NO FURTHER ROOT CAUSE INVESTIGATION HAS BEEN COMPLETED. CORRECTIVE ACTION AS A RESULT OF THE INVESTIGATION: N/A - THIS COMPLAINT DID NOT REQUIRE ESCALATION TO CAPA, THEREFORE NO CAPA PLAN IS AVAILABLE.

    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 WAS HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA. THE BLOOD GLUCOSE LEVEL WAS 400MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INTRAVENOUS INSULIN DRIP. THE TRACE KETONES WERE TESTED POSITIVE WITH VALUE +3. THE PATIENT WAS ADMITTED IN THE HOSPITAL FOR GREATER THAN TWENTY FOUR HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700821 MINIMED QUICK-SET UNO QUICK-SET 110/9 SC1 MECA FPA UNOMEDICAL UM-D MMT-396A 6002446 05705244018051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H