BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 15779812 · Received November 11, 2022

    Report

    Report Number
    3004464228-2022-17655
    Event Type
    Malfunction
    Date Received
    November 11, 2022
    Date of Event
    September 5, 2022
    Report Date
    September 12, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED NOT DEPLOYED. THE DOWNLOAD DATA SHOWS THE DEVICE COMPLETED 45 FIRST PRIME PULSES AND WAS THEN DEACTIVATED AFTER THE COMPLETION OF FIRST PRIME. DURING INVESTIGATION THE DEVICE DEPLOYED NORMALLY UPON MANUAL ROTATION OF THE RATCHET GEAR. NO DAMAGES OR DEFECTS WERE OBSERVED THAT WOULD RESULT IN A FAILURE OF THE CANNULA TO DEPLOY.D4 - SERIAL NO CHANGED FROM 0870884 TO 0670684. D4 - UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4).

    Additional Manufacturer Narrative · 0

    WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. PER SUPPORT TICKET-337500 ¿THE FDA CDRH APPLICATION TEAM RECOGNIZES THAT INDUSTRY FACED SUBMISSION ISSUES AND DELAY IN ACK3 RESPONSES DURING THE MONTH OF SEPTEMBER 2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NEEDLE DID NOT DEPLOY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285948 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L50307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown