BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 14975111 · Received July 11, 2022

    Report

    Report Number
    3004464228-2022-11541
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Date of Event
    June 28, 2022
    Report Date
    June 28, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR 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 COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D1 - BRAND NAME CHANGED FROM UNAVAILABLE TO OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM. D2A - COMMON DEVICE NAME CHANGED FROM UNAVAILABLE TO PUMP, INFUSION, INSULIN. D2B - PROCODE CHANGED FROM UNAVAILABLE TO LZG. CORRECTION TO D(4): MODEL NO CHANGED FROM 18320 TO 18325. CATALOG NO CHANGED FROM UNAVAILABLE TO BLE-P1-525. UNIQUE IDENTIFIER (UDI) # CHANGED TO (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT THEY HAD A POD WHERE THE NEEDLE DEPLOYED EARLY BEFORE THE POD WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029156 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18325 PD1U09222131

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male