BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 11886911 · Received May 26, 2021

    Report

    Report Number
    3004464228-2021-08185
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    May 23, 2021
    Report Date
    May 24, 2021
    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 · 0

    THE POD WAS RECEIVED WITH THE FORMED NEEDLE VISIBLE IN THE EXPOSED PORTION OF THE SOFT CANNULA AND OUTSIDE OF THE NEEDLE WELL, INDICATING THAT THE FORMED NEEDLE DID NOT FULLY RETRACT. THE FORMED NEEDLE DID NOT FULLY RETRACT AFTER OPENING THE POD. INSPECTION OF THE INTERNAL COMPONENTS FOUND THE FORMED NEEDLE TO BE UNSEATED FROM THE SLIDE RETRACT. DAMAGES WERE OBSERVED ON THE FORMED NEEDLE AND SLIDE RETRACT INDICATING THAT THE FORMED NEEDLE HAD BEEN INCORRECTLY INSTALLED INTO THE SLIDE RETRACT. THIS INCORRECT INSTALLATION RESULTED IN THE FORMED NEEDLE BECOMING UNSEATED DURING NEEDLE MECHANISM DEPLOYMENT, RESULTING IN THE FORMED NEEDLE FAILING TO RETRACT AFTER DEPLOYMENT.CORRECTION TO D(4): SEQUENCE NUMBER CHANGED FROM UNAVAILABLE TO 1140707.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. 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. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. THE POD WAS WORN BETWEEN 1 AND 4 HOURS ON THE LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785075 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1C07202051 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1