BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 10104623 · Received June 1, 2020

    Report

    Report Number
    3004464228-2020-07770
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Date of Event
    September 8, 2019
    Report Date
    September 10, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT THAT WAS FILED UNDER ASR EXEMPTION NUMBER E2014031, WHICH HAS BEEN REVOKED. REPORT LATE DUE TO TRANSITION FROM VMSR PROGRAM. THE FOLLOWING ARE THE ID NUMBER OF THE INITIAL ASR REPORT. ASR MANUFACTURER REPORT ID NUMBER: 3004464228-2019-10586 AND 3004464228-2020-01007. REPORT ID NUMBER: CN-932022. EXEMPTION NUMBER: E2014031. THE DEVICE WAS RECEIVED WITH THE CANNULA ASSEMBLY FULLY DEPLOYED. NO ISSUES WERE SEEN WITH THE DEVICE OR THE DATA FROM THE DEVICE. ALTHOUGH NO ISSUES WERE NOTED THAT WOULD RESULT IN A NEEDLE MECHANISM FAILURE, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. ADDITIONALLY, IT WAS OBSERVED THAT THE EXPOSED PORTION OF THE SOFT CANNULA WAS OBSERVED TO BE KINKED. IT COULD NOT BE CONCLUSIVELY DETERMINED WHEN OR WHAT CAUSED THE DAMAGE TO THE EXPOSED PORTION OF THE SOFT CANNULA OR IF IT WAS RELATED TO THE REPORTED EVENT.. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: UST400, 17845-5A-AW REV B 09/17. CHANGING YOUR POD : CHAPTER 3 / PAGES 33. WARNING: CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE DEPLOYED THE CANNULA LATE. THE POD WAS NOT WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569775 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44524 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR