BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 9179240 · Received October 11, 2019

    Report

    Report Number
    3004464228-2019-10098
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    September 5, 2019
    Report Date
    September 25, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K162296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: UST400, 17845-5A-AW REV B 09/17. CHANGING YOUR POD : CHAPTER 3 / PAGES 33; WARNING: CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT.

    Additional Manufacturer Narrative · 1

    CORRECTION: MODEL NO CHANGED FROM 14000 TO 19191. UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4). CORRECTION: PMA/510(K) # CHANGED FROM K122953 TO K162296.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE NEVER DEPLOYED THE CANNULA INTO THE SKIN. THE POD WAS NOT WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975785 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44517 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1