BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIO ADVANCE

    MDR report key: 22662827 · Received July 30, 2025

    Report

    Report Number
    8021545-2025-01990
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    July 9, 2025
    Report Date
    January 26, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018877
    PMA / PMN Number
    K173879
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED INITIAL MDR WITH MANUFACTURING REPORT NUMBER (8021545-2025-01990), WAS SUBMITTED ON 30-JUL-2025. HOWEVER, ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED THE COUNTRY OF OCCURRENCE HAS BEEN UPDATED UNDER B5 (DESCRIPTION OF EVENT). UNOMEDICAL HEREBY SUBMITS THIS SUPPLEMENTAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CAPA/FDA ACTION PLAN. THIS SUBMISSION INCLUDES A RETROSPECTIVE REASSESSMENT OF PREVIOUSLY EVALUATED COMPLAINTS. UNOMEDICAL IS PROVIDING THIS SUPPLEMENTAL INFORMATION IN ACCORDANCE WITH THE REPORTING REQUIREMENTS SET FORTH IN 21 CFR PART 803. ANY FIELDS LEFT BLANK INDICATE THAT THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR REMAINS UNCHANGED. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS INVESTIGATION SUMMARY COMPLAINT INVESTIGATION RESULTS: REVIEW OF COMPLAINT RECORD DATABASE (B)(4). EVENT DESCRIPTION AND ALL AVAILABLE INFORMATION WAS COMPLETED, AND LOT NUMBER 6012484 WAS PROVIDED. COMPLAINT WAS CLASSIFIED UNDER MALFUNCTION CODE SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - REDUCED FLOW A SIMILAR COMPLAINTS SEARCH IN THE ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SYSTEM PERFORMED ON 24-JAN-2026 FOR "LOT NUMBER" "6012484". THREE RECORDS WERE FOUND THAT HAD RELATED MALFUNCTION CODES. DATABASE (B)(4), (B)(4), AND(B)(4). FURTHER TRENDING ANALYSIS ON CANNULA RELATED MALFUNCTION CODES WERE COMPLETED AS PART OF ATTACHED DOCUMENT: MIO ADVANCE CANNULA INVESTIGATION CLOSURE. A QUERY WAS RUN IN THE ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) ON 24-JAN-2026 AGAINST "LOT/BATCH NUMBER" "6012484". NO RECORDS WERE FOUND WITH LOT 6012484 DIRECTLY REFERENCED. A BATCH RECORD REVIEW OF LOT 6012484 SHOWED NO ISSUES RELATED TO REPORTED MALFUNCTION. RETENTION SAMPLES WERE NOT AVAILABLE TO PERFORM TESTING. NO PRODUCTS OR PICTURES WERE RETURNED WITH THE COMPLAINT TO AID IN THE INVESTIGATION. CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN DETERMINATION: BASED ON THE AVAILABLE INFORMATION, NO FURTHER INVESTIGATION IS REQUIRED NOR CAPA PLAN IS NEEDED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING (MONTHLY TRIPS AND ALERTS). SUMMARY CONCLUSION: BASED ON THE AVAILABLE INFORMATION AND THE INVESTIGATION PERFORMED, THE COMPLAINT WILL BE CLOSED AS COMPLAINT UNCONFIRMED AS ANALYZED.

    Additional Manufacturer Narrative · 0

    E1:PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED ARAB EMIRATES. SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Description of Event or Problem · 0

    EVENT COUNTRY: EGYPT. 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 A BENT CANNULA WHICH LED TO HIGH BLOOD GLUCOSE LEVEL. THEREFORE, ON (B)(6) 2025, THE PATIENT FIRST WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVEL. THE PATIENT'S HIGHEST BLOOD GLUCOSE LEVEL WAS 433 MG/DL AND KETONE LEVEL WERE MODERATE. DURING HOSPITALIZATION, THE PATIENT RECEIVED FLUIDS AND INSULIN INTRAVENOUSLY AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE.THE PATIENT WAS RELEASED WITHIN TWENTY FOURS OF ADMISSION. COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45753 MIO ADVANCE UNO MIO ADV. GREY 60/6 SC1 10-PK INT FPA UNOMEDICAL A/S MMT-242A UNKNOWN 05705244018877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention