BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 10399842 · Received August 12, 2020

    Report

    Report Number
    3004464228-2020-12792
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    August 7, 2020
    Report Date
    August 7, 2020
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K162296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RECEIVED DEVICE HAD THE CANNULA ASSEMBLY FULLY DEPLOYED AND THE PINK SLIDE INSERT WAS VISIBLE IN THE VIEWING WINDOW. THE DOWNLOADED DATA SHOWED THAT THE DEVICE RAN 46 FIRST PRIME PULSES AND WAS DEACTIVATED AT 632 PULSES. ALTHOUGH INSPECTION OF THE NEEDLE MECHANISM ASSEMBLY FOUND NO EVIDENCE THAT WOULD RESULT IN THE NEEDLE DEPLOYING EARLY, A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. PER NEW INFORMATION, THE FOLLOWING WERE UPDATED. D1 - BRAND NAME CHANGED FROM OMNIPOD INSULIN PUMP TO OMNIPOD INSULIN MANAGEMENT SYSTEM . D4 - MODEL NO CHANGED FROM 14810 TO 19191. D4 - LOT NO CHANGED FROM BLANK TO L45759. D4 - CATALOG NO CHANGED FROM ZXY425 TO ZXP425. D4 - EXPIRATION DATE CHANGED FROM BLANK TO 11/9/2021. D4 - UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4). G5 - PMA/510(K) # CHANGED FROM K192659 TO K162296. H4 - DEVICE MFG DATE CHANGED FROM BLANK TO 5/9/2020.

    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. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NEEDLE/CANNULA DEPLOYED EARLY INDICATING A NEEDLE MECHANISM FAILURE. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED, AND THE POD WAS NOT WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863908 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191

    Patients

    Seq Age Sex Outcome Treatment
    1