BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 9601343 · Received January 17, 2020

    Report

    Report Number
    3004464228-2020-00549
    Event Type
    Malfunction
    Date Received
    January 17, 2020
    Date of Event
    December 19, 2019
    Report Date
    December 23, 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 AND EVALUATED. SOFT CANNULA WAS IN THE DEPLOYED STATE WHEN THE DEVICE WAS RECEIVED. THE DATA SHOWED THAT THE FIRST PRIMING SEQUENCE ENDED AT 45 PULSES AND DEACTIVATION OCCURRED AT 55 PULSES. ALTHOUGH THE NEEDLE MECHANISM WAS RESET AND FIRED PROPERLY DURING THE INVESTIGATION, THE REPORTED EVENT COULD NOT BE DETERMINED. THE PRODUCT WAS RETURNED WITH A DIFFERENT LOT NUMBER THAN WAS REPORTED AND NOTED ON THE INITIAL MDR. LOT NUMBER CHANGED FROM UNAVAILABLE TO L44894. EXPIRATION DATE CHANGED FROM UNAVAILABLE TO 12/10/2020. MODEL NO CHANGED FROM 14810 TO 19191. PMA/510(K) # CHANGED FROM K122953 TO K162296. UNIQUE IDENTIFIER (UDI) # CHANGED FROM UNAVAILABLE TO (B)(4). DEVICE MFG DATE CHANGED FROM UNAVAILABLE TO 6/10/2019.

    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. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66492 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44894

    Patients

    Seq Age Sex Outcome Treatment
    1