BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3843565 · Received February 11, 2014

    Report

    Report Number
    3004464228-2014-00175
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 15, 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 CUSTOMER REPORTED THAT THE NEEDLE MECHANISM DID NOT DEPLOY. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE PRESSED START ON THE PDM AND THE NEEDLE DID NOT DEPLOY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL REACHED 331 MG/DL. THE POD WAS WORN FOR LESS THAN AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91054 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40518

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR