BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 9545038 · Received January 3, 2020

    Report

    Report Number
    3004464228-2020-00067
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    Date of Event
    December 13, 2019
    Report Date
    December 13, 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 DEVICE WAS RECEIVED WITH THE CANNULA DEPLOYED. NO ISSUES WERE FOUND THAT WOULD RESULT IN THE NEEDLE DEPLOYING LATE. ALTHOUGH NO ISSUES WERE NOTED WITH THE NEEDLE MECHANISM, WE CANNOT DETERMINE WHEN THE DEVICE DEPLOYED.THE PRODUCT WAS RETURNED WITH A DIFFERENT LOT NUMBER THAN WAS REPORTED AND NOTED ON THE INITIAL MDR. CORRECTION TO D(4): LOT NUMBER CHANGED FROM UNAVAILABLE TO L44898. EXPIRATION DATE CHANGED FROM UNAVAILABLE TO 12/12/2020. 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 6/12/2019.

    Additional Manufacturer Narrative · 1

    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. 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

    IT WAS REPORTED THE NEEDLE DEPLOYED LATE; INDICATING A NEEDLE MECHANISM FAILURE. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6525 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44898

    Patients

    Seq Age Sex Outcome Treatment
    1