BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 10105369 · Received June 1, 2020

    Report

    Report Number
    3004464228-2020-07807
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Date of Event
    September 3, 2019
    Report Date
    September 5, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    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    THIS IS AN INITIAL REPORT THAT WAS FILED UNDER ASR EXEMPTION NUMBER E2014031, WHICH HAS BEEN REVOKED.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-925630. 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. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: CAT45E/CAT45F, 15546-AW REV D 06/2016, USING THE POD 5 / PAGE 54. WARNING: CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. YOU SHOULD CHECK YOUR BLOOD GLUCOSE 1.5 TO 2 HOURS AFTER EACH POD CHANGE AND CHECK THE INFUSION SITE PERIODICALLY. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT. VERIFY THERE IS NO WETNESS OR SCENT OF INSULIN, WHERE AS MAY INDICATE THE CANNULA HAS DISLODGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE DEPLOYED THE CANNULA LATE. THE POD WAS NOT WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569431 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L44411

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR