BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED MIO

    MDR report key: 21045347 · Received December 31, 2024

    Report

    Report Number
    3003442380-2024-35223
    Event Type
    Injury
    Date Received
    December 31, 2024
    Date of Event
    November 30, 2024
    Report Date
    August 12, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244020184
    PMA / PMN Number
    K160648
    Adverse Event
    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 ARAB EMIRATES.

    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 FOR THE MALFUNCTION CODE MALFUNCTION CODE NOT ON LIST. THE BATCH 6001412 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. 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. HOWEVER, THE REFERENCE SAMPLES FOR BATCH 6001412 WERE PREVIOUSLY TESTED IN COMPLAINT (B)(4) ON 08/MAY/2024 FOR VISUAL AND FLOW AND COMPLAINT (B)(4) ON 30/MAY/2025 FOR LEAK. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. FUNCTIONAL LEAK TEST 2 ACCORDING TO WORK INSTRUCTION (WI) VERSION 2.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING LOT 6001412 WAS MANUFACTURED ACCORDING TO WI VERSION 62 IN THE LINE 6, ON 24/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD 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 11/AUG/2025 AGAINST MALFUNCTION CODE MALFUNCTION CODE NOT ON LIST AND LOT 6001412 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6001412 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, HARM NO REPORTABLE, NO NON-CONFORMANCE 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.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4) EVENT OCCURRED IN UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT FACED DIABETIC KETOACIDOSIS EVENT AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2024 DUE TO HYPERGLYCEMIA. LENGTH OF HOSPITALIZATION WAS LESS THAN 24 HOURS. THE BLOOD GLUCOSE LEVEL WAS ABOVE 400 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INTRAVENOUS FLUIDS OF INSULIN. NO FURTHER INFORMATION WAS 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
    1846863 MINIMED MIO UNO INSET II 80/9 SC1 GREY MIMX FPA UNOMEDICAL UM-D MMT-975A 6001412 05705244020184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention