BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED INFUSION SET

    MDR report key: 19736699 · Received July 13, 2024

    Report

    Report Number
    8021545-2024-02005
    Event Type
    Malfunction
    Date Received
    July 13, 2024
    Date of Event
    June 8, 2024
    Report Date
    December 17, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244023161
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 02 - MDR (B)(4). CAPA-2010953 "TREND OBSERVED: INCREASE IN COMPLAINTS RELATED TO ADHESIVE ON EWIS" HAS BEEN OPENED ON 18-SEP-2024 TO ADDRESS ALL ADHESIVE ISSUES RELATED TO EWIS PRODUCT FAMILY AS NO SPECIFICATIONS EXIST FOR THE ADHESIVE USED ON THIS PRODUCT (DESIGN RELATED CAPA).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4) - MDR 8021545-2024-02005. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. CAPA-2010953 "TREND OBSERVED: INCREASE IN COMPLAINTS RELATED TO ADHESIVE ON EWIS" HAS BEEN OPENED ON 18-SEP-2024 TO ADDRESS ALL ADHESIVE ISSUES RELATED TO EWIS PRODUCT FAMILY AS NO SPECIFICATIONS EXIST FOR THE ADHESIVE USED ON THIS PRODUCT (DESIGN RELATED CAPA).

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1911090 - MDR 8021545-2024-02005 - DEVICE 1 OF 5. E1: (B)(6).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SETS FELL OFF EVENTS ON (B)(6) 2024. BLOOD GLUCOSE LEVEL REPORTED DURING THE EVENT WAS HIGH. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862328 MEDTRONIC EXTENDED INFUSION SET UNO EWIS BLUE 60/6 HCAP 3-PK INT FPA UNOMEDICAL A/S MMT-431AH 6005666 05705244023161

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown