BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 10113892 · Received June 3, 2020

    Report

    Report Number
    3004464228-2020-08060
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    August 27, 2019
    Report Date
    August 27, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    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    THIS IS AN INITIAL REPORT THAT WAS FILED UNDER ASR EXEMPTION NUMBER E2014031, WHICH HAS BEEN REVOKED.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. REPORT ID NUMBER: CN-914322. EXEMPTION NUMBER: E2014031. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD DASH INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: 18320, 18296-ENG-AW REV B 06/18. CHANGING YOUR POD: CHAPTER 3 / PAGES 48. 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 DID NOT DEPLOY. THE POD WAS NOT WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579297 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1C11161811 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR