BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 9284274 · Received November 6, 2019

    Report

    Report Number
    3004464228-2019-11367
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    October 22, 2019
    Report Date
    October 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 POD 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, IT CANNOT BE DETERMINED WHEN THE DEVICE DEPLOYED.D4 MODEL NO CHANGED FROM 14810 TO 19191. D4 - LOT NO CHANGED FROM BLANK TO L44738. D4 - CATALOG NO CHANGED FROM ZXY425 TO ZXP425. D4 - EXPIRATION DATE CHANGED FROM BLANK TO 10/9/2020. D4 - UNIQUE IDENTIFIER (UDI) # CHANGED FROM BLANK TO (B)(4).L44738(21)0640500. G5 - PMA/510(K) # CHANGED FROM K122953 TO K162296. H4 - DEVICE MFG DATE CHANGED FROM BLANK TO 4/9/2019.

    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

    THE PATIENT REPORTED THE NEEDLE DEPLOYED THE CANNULA 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
    1080953 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44738

    Patients

    Seq Age Sex Outcome Treatment
    1