BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3122510 · Received May 15, 2013

    Report

    Report Number
    3004464228-2013-00441
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 17, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED INFECTION AND HOSPITALIZATION. NO LOT QUALIFICATION RECORDS OR STERILITY RECORDS WERE REVIEWED, AS A PRODUCT LOT NUMBER WAS NOT PROVIDED. THE OMNIPOD USER GUIDE ADVISES "AT LEAST ONCE A DAY, USE THE POD'S VIEWING WINDOW TO INSPECT THE INFUSION SITE. CHECK THE SITE FOR SIGNS OF INFECTION, SUCH AS PAIN, SWELLING, REDNESS, DISCHARGE, OR HEAT." IT CAUTIONS "IF AN INFUSION SITE SHOWS SIGNS OF INFECTION: IMMEDIATELY REMOVE THE POD AND APPLY A NEW ONE AT A DIFFERENT SITE. CONTACT YOUR HEALTHCARE PROVIDER. TREAT THE INFECTION ACCORDING TO INSTRUCTIONS FROM YOUR HEALTHCARE PROVIDER."

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THAT HER SON WAS HOSPITALIZED FOR AN INFECTION AT THE INFUSION SITE. HE WENT TO THE EMERGENCY ROOM AT 11:00 PM AND WAS GIVEN ANTIBIOTICS. HE THEN DEVELOPED A FEVER AND RED STREAKS ON HIS LEG, SO HE WAS ADMITTED TO THE HOSPITAL, WHERE HE WAS KEPT OVERNIGHT AND GIVEN ADDITIONAL ANTIBIOTICS. THE MOTHER DID NOT HAVE ANY FURTHER INFORMATION AND DID NOT KNOW THE LOT AND SEQUENCE NUMBER OF THE POD. SHE WAS ALSO UNSURE IF HER SON STILL HAD THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215300 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization