BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2151608 · Received June 29, 2011

    Report

    Report Number
    3004464228-2011-00317
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POD WILL BE RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM ANY DEVICE MALFUNCTION. THE CUSTOMER HAD "FELT RESISTANCE" DURING THE FILL PROCESS WHICH INDICATES A PROBABLE PROBLEM WITH THE RETAINER THAT ALLOWED A COMPONENT TO MOVE, RESULTING IN INTERNAL DAMAGE TO THE DEVICE. THIS DAMAGE WOULD HAVE PREVENTED THE PLUNGER FROM ADVANCING. THE USER WOULD HAVE BEEN AWARE OF A PROBLEM DURING THE FILL PROCESS. THERE IS RESISTANCE FELT WHEN FILLING THE POD WITH INSULIN AND A DISTINCT "CRACKLING" NOISE RESULTING FROM STRIPPING THE THREADS OF THE COMPONENT WHEN OVER-PRESSURIZED (THOUGH NO CRACKLING NOISE WAS NOTED IN THIS REPORT). ALTHOUGH IT CANNOT BE CONFIRMED THROUGH EVAL, IT IS ASSUMED THAT A DEVICE FAILURE HAD DIRECTLY CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS BASED ON THE SYMPTOMS PROVIDED IN THE REPORT. NO LOT NUMBER WAS PROVIDED - A REVIEW OF LOT QUALIFICATION RECORDS COULD THEREFORE NOT BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE HAD "FELT RESISTANCE" WHEN FILLING THIS POD WITH INSULIN. DESPITE THIS, HOWEVER, SHE PROCEEDED TO WEAR THE DEVICE. PRIOR TO GOING TO BED, SHE HAD EATEN "A LOT OF PIZZA" AND HAD ADMINISTERED A BOLUS. THE FOLLOWING MORNING, SHE "WOKE FEELING SICK WITH DIARRHEA AND VOMITING WITH ELEVATED BLOOD PRESSURE." SHE CHECKED HER BG LEVELS AND ADMINISTERED ANOTHER BOLUS (SPECIFIC BG LEVELS, HOWEVER, WERE NOT PROVIDED). SHE THEN WENT TO THE HOSPITAL AND WAS GIVEN SALINE BECAUSE 'SHE HAD DEHYDRATED." THE POD WAS DISCARDED AND WILL THEREFORE NOT BE RETURNED FOR EVAL. NO SPECIFIC POD ISSUE WAS CITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention