BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 9323159 · Received November 14, 2019

    Report

    Report Number
    3004464228-2019-11937
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    October 15, 2019
    Report Date
    November 1, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    PMA / PMN Number
    K162296
    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. NO ISSUES WERE FOUND THAT WOULD RESULT IN THE NEEDLE DEPLOYING LATE. ALTHOUGH NO ISSUES WERE NOTED WITH THE NEEDLE MECHANISM, IT CANNOT BE DETERMINED WHEN THE DEVICE DEPLOYED.CORRECTION TO D(4): SEQUENCE NUMBER CHANGED FROM 1063785 TO 1060376. UNIQUE IDENTIFIER (UDI) # CHANGED FROM ((B)(4). TO ((B)(4).

    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: ENT450, 17845-5C-AW REV A 10/17. USING THE POD 3/ PAGE 32-33: CHECK THE INFUSION SITE: FOLLOWING INSERTION OF THE CANNULA, CHECK THE INFUSION SITE: LOOK THROUGH THE VIEWING WINDOW TO CHECK THAT THE CANNULA IS INSERTED INTO THE SKIN. THE CANNULA IS TINTED LIGHT BLUE. CHECK FOR PINK COLORING IN THE AREA ON THE TOP OF THE POD SHOWN IN THE FIGURE. THIS IS AN ADDITIONAL CHECK THAT THE CANNULA WAS EXTENDED. CHECK FOR WETNESS OR THE SCENT OF INSULIN AT THE INSERTION SITE. THE PRESENCE OF EITHER MAY INDICATE THAT THE CANNULA HAS DISLODGED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NEEDLE DEPLOYED FIVE MINUTES AFTER THE POD WAS REMOVED, INDICATING A NEEDLE MECHANISM FAILURE. THE POD WAS WORN LESS THAN AN HOUR. NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116803 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44810 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1