BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 9665287 · Received February 4, 2020

    Report

    Report Number
    3004464228-2020-01406
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    January 12, 2020
    Report Date
    January 13, 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 SOFT CANNULA WAS IN THE DEPLOYED STATE WHEN THE DEVICE WAS RECEIVED. THE DATA SHOWED THAT THE FIRST PRIMING SEQUENCE ENDED AT (B)(4) PULSES AND DEACTIVATION OCCURRED AT (B)(4) PULSES. ALTHOUGH THE NEEDLE MECHANISM WAS RESET AND FIRED PROPERLY DURING THE INVESTIGATION, THE REPORTED EVENT COULD NOT BE DETERMINED.D4 - MODEL NO CHANGED FROM 14810 TO 19191. D4 - LOT NO CHANGED FROM BLANK TO L44901. D4 - CATALOG NO CHANGED FROM ZXY425 TO ZXP425. D4 - EXPIRATION DATE CHANGED FROM BLANK TO 12/12/2020. D4 - UNIQUE IDENTIFIER (UDI) # CHANGED FROM BLANK TO (B)(4). G5 - PMA/510(K) # CHANGED FROM K122953 TO K162296. H4 - DEVICE MFG DATE CHANGED FROM BLANK 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. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. 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 PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED AND THE POD WAS NOT WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130529 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44901

    Patients

    Seq Age Sex Outcome Treatment
    1