BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 9897221 · Received March 30, 2020

    Report

    Report Number
    3004464228-2020-04575
    Event Type
    Malfunction
    Date Received
    March 30, 2020
    Date of Event
    March 17, 2020
    Report Date
    March 19, 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 DEVICE WAS RECEIVED AND EVALUATED. THE DOWNLOAD DATA REVEALED THAT THE POD WAS IN POD STATE 14, INDICATING THAT POD ACTIVATION WAS NOT COMPLETED AFTER IT WAS FILLED. THE POD COULD NOT BE ACTIVATED IN THIS STATE AND THUS, BOTH THE NEEDLE DEPLOYMENT AND FLUID DELIVERY WERE PROHIBITED.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 L45179. EXPIRATION DATE CHANGED FROM UNAVAILABLE TO 4/8/2021. 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 10/8/2019.

    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 A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360187 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L45179

    Patients

    Seq Age Sex Outcome Treatment
    1