BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 10643078 · Received October 7, 2020

    Report

    Report Number
    3004464228-2020-15940
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 28, 2020
    Report Date
    September 28, 2020
    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 · 0

    THE POD WAS RECEIVED WITH THE CANNULA DEPLOYED. THE DOWNLOAD DATA SHOWED THAT THE DEVICE RAN 55 PULSES AND WAS DEACTIVATED AFTER COMPLETION OF THE SECOND PRIMING SEQUENCE. NO DEFECTS OR DEFICIENCIES WERE FOUND THAT WOULD RESULT IN A FAILURE OF THE DEVICE TO DELIVER INSULIN. NO ISSUES WERE FOUND THAT WOULD RESULT IN A NEEDLE MECHANISM FAILURE. IT COULD NOT BE DETERMINED WHEN THE NEEDLE DEPLOYED.CORRECTION TO D(4): CATALOG NO CHANGED FROM ZXY425 TO ZXP425. SEQUENCE NUMBER CHANGED FROM UNAVAILABLE TO 0990491. UNIQUE IDENTIFIER (UDI) # CHANGED TO (B)(4).

    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 MECHANISM HAD FULLY DEPLOYED BEFORE THE POD WAS ABLE TO BE USED. THE POD WAS NOT WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109879 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L45815 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1