BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3841206 · Received February 27, 2014

    Report

    Report Number
    3004464228-2014-00240
    Event Type
    Malfunction
    Date Received
    February 27, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 30, 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 EVAL. WE ARE UNABLE TO CONFIRM THE REPORTED BENT CANNULA OR TO DETERMINE IT CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED HER DAUGHTER'S BLOOD GLUCOSE AND INSULIN HISTORY IS AS FOLLOWS: TIME: BEFORE LEAVING SCHOOL, BG (MG/DL): 91. TIME: 11:00 AM, BG (MG/DL): 190, BOLUS (U) 1.75 (THE NURSE PROGRAM A BOLUS DELIVERY. SHE STATED THERE WAS BLOOD NOTED IN THE CANNULA. SHE ALSO NOTICED THE CANNULA WAS BENT AND IT WAS SLANTED TO THE LEFT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122732 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40678

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR