BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED MIO

    MDR report key: 21110129 · Received January 9, 2025

    Report

    Report Number
    3003442380-2024-36481
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 14, 2024
    Report Date
    June 26, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244020184
    PMA / PMN Number
    K160648
    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 6001412 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 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE CODE TUBING DETACHED FROM TUBING-TUBING CONNECTOR. COMPLAINT INVESTIGATIONS: 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. FUNCTIONAL STATIC PULL TEST TUBING-TUBING CONNECTOR TEST 1 ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001412 WAS MANUFACTURED ACCORDING TO THE WI VERSION 62 IN THE LINE 6, ON 24/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING: THE LOT 3E02676 WAS GLUED ACCORDING TO THE WI VERSION 55, MACHINE SCO8, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING: THE LOT 3E03164 WAS GLUED ACCORDING TO THE WI VERSION 55, MACHINE SCO8, 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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TRENDING: A QUERY WAS RUN IN DATABASE ON 23/MAY/2025 AGAINST MALFUNCTION CODE TUBING DETACHED FROM TUBING-TUBING CONNECTOR AND LOT 6001412, WITH NO TREND IDENTIFIED. 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.

    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 FACED INFUSION SET TUBE DETACHMENT EVENT ON 14-DEC-2024. THE SITE OF DETACHMENT WAS FROM QUICK RELEASE. THE INFUSION SET WAS IN USE FOR ONE DAY. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352331 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