BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3170133 · Received June 6, 2013

    Report

    Report Number
    3004464228-2013-00568
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    INSULET CORP
    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 DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED INFECTION AND HYPERGLYCEMIA. 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 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 FORM YOUR HEALTHCARE PROVIDER." IT ADVISES, "AT LEAST ONCE A DAY, USE THE POD'S VIEWING WINDOW TO INSPECT THE INFECTION SITE. CHECK THE SITE FOR SIGNS OF INFECTION, SUCH AS PAIN, SWELLING, REDNESS, DISCHARGE, OR HEAT." IT ALSO WARNS, "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER WEARING A POD FOR 48 HOURS, SHE REMOVED THE POD AND THE SITE WAS SWOLLEN "TO THE SIZE OF A POD". SHE SAID THAT HER BLOOD GLUCOSE RESULT REACHED APPROXIMATELY 400 MG/DL, AND THE AREA WAS WHITE WITH NO DISCHARGE. SHE APPLIED HOT COMPRESSES AND TREATED IT WITH ANTIBIOTICS FROM HER HEALTH CARE PRACTITIONER. SHE STATED THAT SHE CLEANSES THE SITE AREAS WITH SOAP AND WATER. SHE DISCARDED THE POD PRIOR TO CALLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252013 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORP 11200 L31036

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other