BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED MIO

    MDR report key: 21166496 · Received January 16, 2025

    Report

    Report Number
    3003442380-2024-36917
    Event Type
    Injury
    Date Received
    January 16, 2025
    Date of Event
    December 16, 2024
    Report Date
    August 18, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244019942
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    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: THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6003873 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3.0 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2.0 FOR THE CODE OCCLUSION (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). COMPLAINT INVESTIGATIONS. PHYSICAL SAMPLES WERE FORMALLY REQUESTED; HOWEVER, THEY WERE NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WI VERSION 2.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING LOT 6003873 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65 IN THE LINE 6, ON 18/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING LOT 3K02267 WAS MANUFACTURED ACCORDING TO THE WI VERSION 56, GLUING OF TUBING IN THE MACHINE SC02, ON 15/OCT/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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 05/AUG/2025 AGAINST MALFUNCTION CODE OCCLUSION (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED) AND LOT 6003873 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6003873 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON 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: AUSTRALIA.

    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 AUSTRALIA IT WAS REPORTED THAT THE PATIENT FACED DIABETIC KETOACIDOSIS EVENT AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2024 DUE TO INSULIN FLOW BLOCKED. LENGTH OF HOSPITALIZATION LESS THAN 24 HOURS. THE BLOOD GLUCOSE LEVEL WAS 16.3 MMOL/L AND THE PATIENT WAS TREATED WITH CORRECTION VIA INJECTIONS. KETONES WERE REPORTED 0.1. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251740 MINIMED MIO UNO INSET II 60/6 SC1 PINK MIMX FPA UNOMEDICAL UM-D MMT-923A 6003873 05705244019942

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention