BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3931377 · Received April 11, 2014

    Report

    Report Number
    3004464228-2014-00478
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 15, 2014
    Report Date
    March 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 DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    SEE SCANNED TABLE. THE CUSTOMER REPORTED THAT WHEN SHE REMOVED THE POD, SHE NOTICED THAT THE CANNULA WAS BENT, THERE WAS SOME BLOOD AROUND THE INSERTION SITE, AND THE ADHESIVE SMELLED OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220100 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40718

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR