BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 10367579 · Received August 5, 2020

    Report

    Report Number
    3004464228-2020-12388
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    July 17, 2020
    Report Date
    July 24, 2020
    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

    CHANGED D4 DEVICE SERIAL NUMBER FROM: 1181065 TO 1181056 CHANGED D4 UDI NUMBER FROM :(B)(4) 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. FOR YOUR REFERENCE, INSULET MODIFIED OUR INTERNAL INVESTIGATION FINDING CODES EFFECTIVE 25 MAY 2020 AS PART OF AN EFFORT TO IMPROVE THE CLASSIFICATION OF FINDINGS TO IMPROVE THE POWER OF TRENDING DATA AND MAKE THE FINDINGS MORE INTUITIVE. THE NEW FINDINGS CODES WILL USE THE SYSTEM OF FINDING CATEGORY (E.G. HARDWARE COMPONENT), FOLLOWED BY THE AFFECTED COMPONENT (E.G. NEEDLE), FOLLOWED BY THE CONDITION (E.G. BENT). THEREFORE YOU MAY NOTICE FINDINGS THAT APPEAR TO BE NEW OR DIFFERENT BUT IN FACT ARE JUST RENAMED FOR IMPROVED DATA VALUE. INSULET WOULD BE HAPPY TO EXPLAIN ANY MAPPING OF THE OLD TO NEW FINDING CODES IF YOU HAVE ANY QUESTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE DEPLOYED EARLY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE. THE POD WAS NOT WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835153 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1C12141951 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR