BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 5233329 · Received November 18, 2015

    Report

    Report Number
    3004464228-2015-01937
    Event Type
    Injury
    Date Received
    November 18, 2015
    Date of Event
    May 14, 2015
    Report Date
    June 1, 2015
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULET CORPORATION IS SUBMITTING THIS MDR THAT WAS PREVIOUSLY IDENTIFIED FOR INCLUSION IN THE Q2 2015 ALTERNATIVE SUMMARY REPORT (ASR). THIS MDR IS BEING SUBMITTED AFTER THE 30 DAY REQUIREMENT DUE TO ERRONEOUS IDENTIFICATION FOR INCLUSION INTO THE Q2 2015 ASR. THIS ERROR WAS COMMUNICATED TO FDA ON JULY 31ST, 2015 WHEN WE SUBMITTED A REQUEST FOR PERMISSION TO SUBMIT A RETROSPECTIVE SUMMARY REPORT (RSR) UNDER 21 CFR PART 803.19. FDA DECLINED INSULET PARTICIPATION IN THE RSR PROGRAM IN A DECISION DATED AUGUST 26, 2015 AND EMAILED ON SEPTEMBER 3, 2015. AS A RESULT, INSULET IS COMMITTED TO COMPLETE THESE CORRECTIONS THROUGH THIS SUBMISSION. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO CUSTOMER'S INFUSION SITE INFECTION. RELEASE AND STERILIZATION RECORDS WERE REVIEWED AND THE PRODUCT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS "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 "CHECK THE SITE FOR SIGNS OF INFECTION, SUCH AS PAIN, SWELLING, REDNESS, DISCHARGE OR HEAT."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE HAD AN INFECTION AT THE INSERTION SITE AFTER WEARING THE POD AFTER 48 HOURS. THE PATIENT WENT TO THE URGENT CARE AND WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763149 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L41589

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other