BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED MIO

    MDR report key: 21341339 · Received February 9, 2025

    Report

    Report Number
    3003442380-2025-00791
    Event Type
    Injury
    Date Received
    February 9, 2025
    Date of Event
    January 9, 2025
    Report Date
    July 2, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244020030
    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. THE BATCH 6001858 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 FOR THE ADHESIVE PATCH LIFTS OR DETACHES DURING USE. PHOTO/SAMPLE WAS 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 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001858 WAS MANUFACTURED ACCORDING TO THE WI VERSION 63 MANUFACTURED IN THE LINE INSET 4, ON 12/JUN/2023, WITH A TOTAL OF (B(6) 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; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 01/JUL/2025 AGAINST MALFUNCTION CODE ADHESIVE PATCH LIFTS OR DETACHES DURING USE AND LOT 6001858 AND NO MORE COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, 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 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 WENT TO EMERGENCY ROOM AND GOT HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIC AND TAPE WAS NOT STICKING EVENT. INFUSION SET WAS USE FOR 3 DAYS. BLOOD GLUCOSE LEVEL WAS 350 MG/DL AT THE TIME OF THE EVENT. PATIENT WAS FOUND POSITIVE FOR KETONES LEVEL. PATIENT EXPERIENCED THE SYMPTOMS OF THROWING UP. THE DURATION OF HOSPITALIZATION WAS 2 HOURS. PATIENT GOT TREATED WITH INSULIN VIA MANUAL INJECTION AT THE HOSPITAL. 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
    960562 MINIMED MIO UNO INSET II 60/6 SC1 BLUE MIMX FPA UNOMEDICAL UM-D MMT-943A 6001858 05705244020030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention