BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC EXTENDED

    MDR report key: 21155302 · Received January 15, 2025

    Report

    Report Number
    8021545-2024-05074
    Event Type
    Injury
    Date Received
    January 15, 2025
    Date of Event
    December 11, 2024
    Report Date
    January 24, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022683
    PMA / PMN Number
    K210544
    Adverse Event
    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 LOT NUMBER AND EXPIRY DATE UNDER D4, MANUFACTURING DATE UNDER H4. 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. H11: INVESTIGATION SUMMARY - COMPLAINT INVESTIGATION RESULTS: REVIEW OF COMPLAINT RECORD DATABASE (B)(4) EVENT DESCRIPTION AND ALL AVAILABLE INFORMATION WAS COMPLETED, AND LOT NUMBER 6003237 WAS PROVIDED. COMPLAINT WAS CLASSIFIED UNDER MALFUNCTION CODE: ADHESIVE PATCH COMPLETELY DETACHES DURING USE- DETACHMENT / SIGNIFICANT WETNESS. A SIMILAR COMPLAINTS SEARCH IN THE ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SYSTEM PERFORMED ON 24-JAN-2026 FOR AGAINST "LOT NUMBER" "6003237" NO SIMILAR COMPLAINTS WERE IDENTIFIED FOR THIS LOT AND ADHESIVE RELATED ISSUES. A QUERY WAS RUN IN THE EQMS ON 24-JAN-2026 AGAINST "BATCH/LOT NUMBER" "6003237" UNDER CAPA FAMILY SCOPE. NO RECORDS WERE FOUND WITH LOT 6003237 REFERENCED. REVIEW OF BATCH RECORD 6003237 SHOWED ALL SPECIFICATION MET AND NO ISSUES IDENTIFIED FOR ADHESION ISSUES. CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION: DURING THE INVESTIGATION CAPA-2010953 WAS IDENTIFIED, IT WAS OPENED 18-SEP-2024 FOR ADHESIVE RELATED COMPLAINT AND BOUNDING COVERS MEDTRONIC EXTENDED (EWIS) PRODUCTS AND THE TIME PERIOD REVIEW. CORRECTIVE ACTION AS A RESULT OF THE INVESTIGATION: DATABASE -(B)(4) OPENED TO REVIEW DESIGN INPUTS FOR 7-DAY ADHESIVE. DATABASE -(B)(4) OPENED TO COMPLETE ASSOCIATED METHOD VALIDATION AND VERIFICATION TESTING. DATABASE-(B)(4) OPENED TO REVIEW AND UPDATE EWIS RISK MANAGEMENT FILE WITH UPDATED TEST RESULTS, AND TO CORRECTLY MAP HARMS AND SEVERITIES IN LINE WITH IC PORTFOLIO SUMMARY CONCLUSION: BASED ON THE LACK OF LOT SPECIFIC INFORMATION, NO PRODUCTS RETURNED TO TEST, AND CAPA-2010953 INVESTIGATION CONCLUSION, THE COMPLAINT WILL BE CLOSED AS COMPLAINT UNCONFIRMED AS ANALYZED.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED KINGDOM. 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

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED KINGDOM. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2024 DUE TO HYPERGLYCEMIA AND INFUSION SET UNSTUCK EVENT. BLOOD GLUCOSE LEVEL WAS 540 MMOL/L AT THE TIME OF THE EVENT. THE DURATION OF HOSPITALIZATION WAS 24 HOURS. PATIENT WAS FOUND POSITIVE FOR KETONES LEVEL. PATIENT EXPERIENCED THE SYMPTOMS OF SHALLOW BREATHING. PATIENT WAS TREATED WITH INSULIN VIA INTRAVENOUS DRIP (IV). NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515730 MEDTRONIC EXTENDED UNO EWIS BLUE 60/6 HCAP 10PK INT FPA UNOMEDICAL A/S MMT-431A 6003237 05705244022683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R