BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3070596 · Received April 11, 2013

    Report

    Report Number
    3004464228-2013-00334
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 15, 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 DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO ASSESS THE PRODUCT CONDITION. NO REVIEW OF QUALIFICATION AND STERILIZATION RECORDS WAS POSSIBLE BECAUSE NO PRODUCT LOT NUMBER WAS REPORTED. THE OMNIPOD USER GUIDE WARNS "TO MINIMIZE THE POSSIBILITY OF SITE INFECTION, DO NOT APPLY A POD WITHOUT FIRST USING ASEPTIC TECHNIQUE. THIS MEANS TO WASH YOUR HANDS, CLEAN THE INSULIN VIAL WITH AN ALCOHOL PREP SWAP, CLEAN THE INFUSION SITE WITH SOAP AND WATER, AND KEEP STERILE MATERIALS AWAY FROM ANY POSSIBLE GERMS., " 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 AND TREAT THE INFECTION ACCORDING TO INSTRUCTIONS FROM YOUR HEALTHCARE PROVIDER." AND 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."

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED BY EMAIL THAT HER DAUGHTER HAD AN IRRITATION AT THE INFUSION SITE THAT TURNED INTO AN INFECTION. SHE WAS ON ORAL ANTIBIOTICS FOR THREE AND A HALF WEEK AND THEN HOSPITALIZED FOR FOUR NIGHTS ON IV ANTIBIOTICS AND ONLY "SEEING SMALL STEPS OF PROGRESS." THE INFECTION HAS BEEN IDENTIFIED BY THE HOSPITAL DOCTORS AS MYCOBACTERIUM PORCINUM. SHE ALSO STATE THAT HER DAUGHTER'S LIVER ENZYMES HAD BEEN AS HIGH AS 170 THE WEEK BEFORE HER REPORT AND THAT HER DAUGHTER IS COMPLAINING OF PAIN AT THE SITE. THE POD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155167 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| O