BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 9304271 · Received November 11, 2019

    Report

    Report Number
    3004464228-2019-11674
    Event Type
    Malfunction
    Date Received
    November 11, 2019
    Date of Event
    October 29, 2019
    Report Date
    October 30, 2019
    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 RETURNED DEVICE WAS EVALUATED AND THE SOFT CANNULA WAS IN THE DEPLOYED STATE WHEN THE DEVICE WAS RECEIVED. THE DATA SHOWED THAT THE FIRST PRIMING SEQUENCE ENDED AT 46 PULSES AND DEACTIVATION OCCURRED AT 58 PULSES. ALTHOUGH THE NEEDLE MECHANISM WAS RESET AND FIRED PROPERLY DURING THE INVESTIGATION, THE REPORTED EVENT COULD NOT BE DETERMINED.CORRECTION TO D(4): LOT NUMBER CHANGED FROM UNAVAILABLE TO L44772. EXPIRATION DATE CHANGED FROM UNAVAILABLE TO (B)(6)2020 . MODEL NO CHANGED FROM 14810 TO 19191. CORRECTION TO G(5): PMA/510(K) # CHANGED FROM K122953 TO K162296. UNIQUE IDENTIFIER (UDI) # CHANGED FROM UNAVAILABLE TO (B)(4). CORRECTION TO H(4): DEVICE MFG DATE CHANGED FROM UNAVAILABLE TO 4/20/2019.

    Additional Manufacturer Narrative · 1

    THE PRODUCT 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 BECAUSE NO PRODUCT LOT NUMBER WAS REPORTED. MYLIFE OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: ENT450, 14518-5C-AW REV E 03/16. USING THE POD 5 / PAGE 53: 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

    THE PATIENT REPORTED THAT THE NEEDLE DEPLOYED THE CANNULA EARLY. THE POD WAS NOT WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101239 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44772

    Patients

    Seq Age Sex Outcome Treatment
    1