BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 10134058 · Received June 9, 2020

    Report

    Report Number
    3004464228-2020-08707
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    September 12, 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    THIS IS A SUPPLEMENTAL REPORT THAT WAS FILED UNDER AN INITIAL ASR REPORT FOR EXEMPTION NUMBER E2014031, WHICH HAS BEEN REVOKED.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-935463. EXEMPTION NUMBER: E2014031. THE POD WAS RECEIVED WITH THE CANNULA DEPLOYED, WITH AN EXPECTED NUMBER OF PULSES IN EACH PRIMING SEQUENCE. NO ISSUES WERE FOUND THAT WOULD RESULT IN THE NEEDLE DEPLOYING LATE. ALTHOUGH NO ISSUES WERE NOTED WITH THE NEEDLE MECHANISM, WE CANNOT DETERMINE WHEN THE DEVICE DEPLOYED. 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
    598077 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L43971 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR