BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2233972 · Received August 31, 2011

    Report

    Report Number
    3004464228-2011-00548
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION - WE ARE UNABLE TO EVALUATE THE ADHESIVE PAD FOR ANY ABNORMALITY THAT MAY HAVE CAUSED THE CUSTOMER'S SKIN INFECTION. IT IS KNOWN AND UNDERSTOOD BY THE MANUFACTURER THAT, BASED ON CUSTOMER'S INDIVIDUAL SKIN SENSITIVITIES, VARIOUS REACTIONS TO THE POD'S ADHESIVE MAY BE EXPERIENCED. THE OMNIPOD USER GUIDE CONTAINS A SECTION DEDICATED TO INFECTIONS TITLED "AVOID INFUSION SITE INFECTIONS" THAT INCLUDES THE FOLLOWING INFORMATION: ALWAYS WASH HANDS AND USE ASEPTIC TECHNIQUE BEFORE APPLYING A POD; DON'T APPLY A POD TO ANY AREA OF SKIN WITH AN ACTIVE INFECTION; AT LEAST ONCE PER DAY, CHECK THE INFUSION SITE FOR SIGNS OF INFECTION; SIGNS OF INFECTION INCLUDE PAIN, SWELLING, REDNESS, DISCHARGE OR HEAT - IF INFECTION IS SUSPECTED, IMMEDIATELY REMOVE THE POD AND CONTACT A HEALTH CARE PROVIDER. TO MITIGATE THE RECURRENCE OF ADVERSE SKIN CONDITIONS, THE OMNIPOD WEBSITE OFFERS A RESOURCE GUIDE THAT INCLUDES A LISTING OF SKIN BARRIER PRODUCTS THAT CAN BE USED TO PROTECT THE INFUSION SITE. INSULET PERFORMS A REVIEW OF CUSTOMER COMPLAINT DATA; THE OCCURRENCE RATE OF REPORTED INFECTIONS AT THE INFUSION SITE IS ( AND HAS HISTORICALLY BEEN) SIGNIFICANTLY BELOW THE LEVEL AT WHICH AN INTERNAL CORRECTIVE ACTION WOULD BE REQUIRED (PER INSULET'S INTERNAL CORRECTIVE AND PREVENTIVE ACTION PROCEDURES). HOWEVER, INSULET HAS INITIATED ACTION TO DETERMINE IF MARKETING CAN IMPROVE EDUCATION AND TRAINING RELATED TO THIS TOPIC. NOTE: A REVIEW OF LOT QUALIFICATION RECORDS COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER WAS ON HER SECOND DAY OF POD WEAR WHEN SHE "STARTED TO FEEL PAIN" AT THE INSERTION SITE. SHE REMOVED THE POD AND NOTICED"PUSTULANT LEAKAGE" AT THE SITE "WITH REDNESS AND TENDERNESS." SINCE HER FATHER IS A PHYSICIAN, HE "WAS ABLE TO PROVIDE HER WITH A PRESCRIPTION FOR ANTIBIOTICS." SINCE THE USE OF THE ANTIBIOTICS, THE INFECTED SITE HAS BEEN "HEALING." THE CUSTOMER PREPS THE POD SITE WITH ALCOHOL BEFORE APPLICATION AND USES MASTISOL FOR ADHESIVE ISSUES. SHE COULD NOT FIND THE POD AND WILL THEREFORE NOT BE RETURNING IT FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention