BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 10107019 · Received June 1, 2020

    Report

    Report Number
    3004464228-2020-07728
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Date of Event
    July 27, 2019
    Report Date
    September 12, 2019
    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 · 1

    THIS IS AN INITIAL REPORT THAT WAS FILED UNDER ASR EXEMPTION NUMBER E2014031, WHICH HAS BEEN REVOKED. REPORT LATE DUE TO TRANSITION FROM VMSR PROGRAM. THE FOLLOWING ARE THE ID NUMBER OF THE INITIAL ASR REPORT ASR MANUFACTURER REPORT ID NUMBER: 3004464228-2019-10586. REPORT ID NUMBER: CN-935102. EXEMPTION NUMBER: E2014031. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. 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 THAT THE CANNULA DID NOT DEPLOY. THE POD WAS NOT WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569331 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR