BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 10107015 · Received June 1, 2020

    Report

    Report Number
    3004464228-2020-07730
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Date of Event
    September 10, 2019
    Report Date
    September 12, 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    THIS IS A SUPPLEMENTAL REPORT THAT WAS FILED UNDER AN INITIAL ASR REPORT FOR EXEMPTION NUMBER E2014031, WHICH HAS BEEN REVOKED.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-935213. EXEMPTION NUMBER: E2014031. DATA DOWNLOAD SHOWS THAT PRIME ONE ENDED AT 46 PULSES AND PRIME TWO COMPLETED AT 56 PULSES. THE POD WAS RECEIVED WITH THE DEVICE FULLY DEPLOYED AND NO DAMAGE OR DEFECTS WERE IDENTIFIED ON THE NEEDLE MECHANISM ASSEMBLY. NO PROBLEMS WERE FOUND THAT WOULD CAUSE THE NEEDLE TO DEPLOYED LATE OR DISRUPT THE POD'S DELIVERY OF INSULIN. ALTHOUGH NO DAMAGE WAS PRESENT AND PULSE COUNT SHOWED THAT THE POD WAS IN THE CORRECT STATE TO DEPLOY, THE REPORTED EVENT COULD NOT BE DETERMINED. 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
    569326 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44836 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR