BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3961457 · Received May 29, 2014

    Report

    Report Number
    3004464228-2014-00735
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 3, 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 A DISLODGED CANNULA. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA IF IT OCCURRED. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HER BLOOD GLUCOSE, CARBOHYDRATE INTAKE AND INSULIN HISTORY IS AS FOLLOWS: TIME: 7:00AM; BG (MG/DL): 179; CHO (G): 34; BOLUS (U): 1.5; 9:20AM; "HIGH" (>500); 9:21 AM; 478; 2.0 (MANUAL INJECTION). UPON INSPECTION, SHE NOTICED THE ADHESIVE PAD WAS WET AND THE CANNULA WAS OUT OF HER SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315902 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40817

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR