BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4120691 · Received July 25, 2014

    Report

    Report Number
    3004464228-2014-01064
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    June 28, 2014
    Report Date
    June 28, 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 RETURNED PRODUCT WAS EVALUATED AND PERFORMED AS DESIGNED. NO DEFECT OR DEFICIENCY THAT WOULD RESULT IN THE CANNULA FAILING TO INSERT CORRECTLY OR THE PUMP FAILING TO DELIVER INSULIN WAS FOUND. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE REACHED 274 MG/DL AND THAT THE CANNULA DISLODGED FROM THE INFUSION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436932 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L41000

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR