BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 11683126 · Received April 17, 2021

    Report

    Report Number
    3004464228-2021-05705
    Event Type
    Malfunction
    Date Received
    April 17, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 6, 2021
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FULLY DEPLOYED. NO TIMEOUTS OR DRIVE STALLS WERE SEEN IN THE DOWNLOAD DATA. THE DATA INDICATES THAT THE DEVICE COMPLETED BOTH FIRST AND SECOND PRIME BEFORE BEING DEACTIVATED. THE NEEDLE MECHANISM WAS RESET TO THE NOT DEPLOYED POSITION, AND THE DEVICE FUNCTIONED AS INTENDED DURING MANUAL DEPLOYMENT. NO DAMAGES OR DEFECTS WERE OBSERVED THAT WOULD RESULT IN THE NEEDLE DEPLOYING EARLY. ALTHOUGH NO PROBLEMS WERE FOUND, IT COULD NOT BE DETERMINED WHEN THE DEVICE DEPLOYED. THE SOFT CANNULA WAS OBSERVED TO BE KINKED. IT IS UNKNOWN HOW OR WHEN THE KINK OCCURRED. INSULIN WAS ABLE TO FREELY EXIT THE DISTAL TIP OF THE SOFT CANNULA DESPITE THE CANNULA BEING DAMAGED.CORRECTION TO D(4): CATALOG NO CHANGED FROM ZXY425 TO ZXP425. SEQUENCE NUMBER CHANGED FROM 02125 TO 0021256. EXPIRATION DATE CHANGED FROM UNAVAILABLE TO 5/2/2022. MODEL NO CHANGED FROM 14810 TO 19191. UNIQUE IDENTIFIER (UDI) # CHANGED TO (B)(4). DEVICE MFG DATE CHANGED FROM UNAVAILABLE TO 11/2/2020.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. 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 DEPLOYED EARLY. THE POD WAS NOT WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580514 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L46043

    Patients

    Seq Age Sex Outcome Treatment
    1 121 YR