BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3802842 · Received May 1, 2014

    Report

    Report Number
    3004464228-2014-00583
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    March 30, 2014
    Report Date
    April 3, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO ASSESS IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE PATIENT'S INFECTION AND HYPERGLYCEMIA. QUALIFICATION AND STERILIZATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD'S USER GUIDE WARNS TO "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 OR AN ALCOHOL PREP SWAB AND KEEP STERILE MATERIALS AWAY FROM ANY POSSIBLE GERMS," "IF AN INFUSION SITE SHOWS SIGNS OF INFECTION; IMMEDIATELY REMOVE THE POD AND APPLY A NEW ONE AT A DIFFERENT SITE. CONTACT YOUR HEALTHCARE PROVIDED. TREAT THE INFECTION ACCORDING TO INSTRUCTIONS FROM YOUR HEALTHCARE PROVIDER," AND "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER." 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."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ON (B)(6) 2014 HER BLOOD GLUCOSE AND INSULIN HISTORY IS AS FOLLOWS: TIME - 6:00 AM. BG (MG/DL) - 270 AND 273. BOLUS (U) - 1.0. TIME - 7:00 AM. BG (MG/DL) - 330 (AFTER SHE WORKED OUT FOR 45 MINUTES). HER SITE WAS HURTING SO MUCH THAT SHE DECIDED TO REMOVE THE POD. SHE THEN NOTICED THE SITE WAS RED, IRRITATED AND THERE WAS ALSO A LUMP WITH A POCKET OF PUS. SHE WENT TO SEE HER HEALTHCARE PROVIDER WHO PRESCRIBED HER WITH "KEFLEX" ANTIBIOTIC FOR HER SITE INFECTION. HER BG REACHED 400 MG/DL AND SHE GAVE A MANUAL INJECTION OF INSULIN BUT WAS UNABLE TO LOWER HER BG SO SHE CALLED HER ENDOCRINOLOGIST WHO SUGGESTED SHE USE ANOTHER BOTTLE OF INSULIN. SHE STATED THE ANTIBIOTIC SEEMED TO BE WORKING BY THE NEXT DAY HER SITE WAS NOT AS RED AS IT WAS INITIALLY BUT THE LUMP IS STILL THERE. SHE IS DOING BETTER NOW AND SHE CURRENTLY STILL ON THE ANTIBIOTIC AT THE TIME OF THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261136 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40888

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other