BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4093064 · Received September 10, 2014

    Report

    Report Number
    3004464228-2014-01339
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 10, 2014
    Report Date
    August 12, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE (TO RETRACT), TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA, OR TO DETERMINE THE ROOT CAUSE. NO PRODUCT LOT NUMBER WAS REPORTED THEREFORE NO QUALIFICATION RECORDS WERE REVIEWED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HER BLOOD GLUCOSE REACHED 280 MG/DL AFTER WEARING THE POD FOR 3 DAYS. SHE FELT PAIN AT THE SITE AND UPON REMOVAL SHE NOTICED THE NEEDLE DID NOT RETRACT BACK INTO THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559850 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR