BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3143206 · Received May 28, 2013

    Report

    Report Number
    3004464228-2013-00497
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 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, HOSPITALIZATION AND SURGERY. LOT QUALIFICATION RECORDS, INCLUDING STERILITY RECORDS, WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. 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 SWAB. CLEAN THE INFUSION SITE WITH SOAP AND WATER. KEEP STERILE MATERIALS AWAY FROM ANY POSSIBLE GERMS" AND IT 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 REPORTED THAT BECAUSE OF PAIN, HE REMOVED A POD AND HAD A "HUGE" BUMP ON HIS LEG. HE COULD NOT APPLY PRESSURE. HE CALLED BACK TO REPORT THAT HE WENT TO THE HOSPITAL ON (B)(6). HE WAS DIAGNOSED WITH AN INFECTION AND GIVEN OINTMENT, ANTIBIOTICS AND TYLENOL. HE WAS IN A LOT PAIN, AND THE BUMP HAD DOUBLED IN SIZE. HIS BLOOD GLUCOSE RESULTS WERE NORMAL. HE WENT HOME THAT DAY AND WAS ADVISED TO RETURN IF THE SWELLING DID NOT GO DOWN BY THE NEXT DAY, AS IT COULD BE SEVERE. THE NEXT DAY, HE RETURNED IN PAIN AND WAS HOSPITALIZED. ON (B)(6), HE CALLED TO REPORT THAT HE WAS STILL HOSPITALIZED. HE WAS ON INTRAVENOUS FLUIDS, AN INSULIN DRIP, TWO INTRAVENOUS ANTIBIOTICS, AND ORAL ANTIBIOTICS. HE WAS GIVEN MORPHINE AND PERCOCET FOR PAIN. HE WAS DIAGNOSED WITH CELLULITIS, AND TOLD SURGERY MAY BE NEEDED, INCLUDING POSSIBLE AMPUTATION. HE STATED THE INFECTION STARTED AT THE INSERTION SITE AND SPREAD TO HIS KNEE, GROIN, AND BACK OF HIS HAMSTRING AREA. HE HAD AN ABSCESS UNDER THE SITE AREA THE SIZE OF A SOFTBALL. ON (B)(6), HE CALLED TO REPORT THAT HE WOULD HAVE AN ULTRASOUND AND THEN SURGERY TO REMOVE THE ABSCESS. HE SAID HE WOULD BE BEDRIDDEN AND OUT OF WORK FOR 2 WEEKS AND WOULD NEED TO GO TO A CLINIC DAILY TO HAVE THE SITE CLEANED AND DRESSED. HE SAID THAT A BACTERIAL CULTURE HAD BEEN DONE AND HE WAS AWAITING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233346 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14820 L31055

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization