BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIO ADVANCE

    MDR report key: 20158658 · Received September 6, 2024

    Report

    Report Number
    8021545-2024-03549
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 9, 2024
    Report Date
    February 17, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018907
    PMA / PMN Number
    K173879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 8021545-2024-03549. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D9: DEVICE AVAILABLE FOR EVALUATION HAS BEEN SELECTED AS YES & DATE RETURNED TO MFG WAS ADDED AS WELL. H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1965186- - MDR DEVICE 2 OF 2. E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES. SINCE NO LOT NUMBER IS AVAILABEL, A DETAILED INVESTIGATION, TESTS OR REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONCLUDED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WOULD FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Description of Event or Problem · 0

    TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4).EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED TWO INFUSION SETS LEAKAGE IN THE TUBING. THE BLOOD GLUCOSE LEVEL WAS REPORTED 347 MG/DL AND TREATED WITH BOLUS. NO FURTHER INFORMATION AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2074287 MIO ADVANCE UNO MIO ADV. GREY 60/9 SC1 10-PK INT FPA UNOMEDICAL A/S MMT-243A UNKNOWN 05705244018907

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown