BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4232325 · Received October 22, 2014

    Report

    Report Number
    3004464228-2014-01586
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 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. THE USER REPORTED THAT HE WAS UNABLE TO VIEW IF THE CANNULA WAS PROPERLY INSERTED BUT WAS ABLE TO FEEL INSULIN ON HIS SKIN AT THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIS BLOOD GLUCOSE REACHED 310 MG/DL LESS THAN 4 HOURS AFTER THE POD WAS ACTIVATED. HE WAS NOT ABLE TO SEE IF THE CANNULA WAS PROPERLY INSERTED OR NOT BUT DURING A BOLUS DELIVERY HE NOTICED THAT THE INSULIN WAS DELIVERING OUTSIDE OF HIS SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670724 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 1400 L41174

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR