BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2090133 · Received May 5, 2011

    Report

    Report Number
    3004464228-2011-00192
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 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 EVAL. 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 MFR 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 INFO: 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 REMOVED 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 PROTECTED INFUSION SITE. TWICE PER MONTH, 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. A REVIEW OF LOT QUALIFICATION RECORDS COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. NOTE: WITHOUT THE POD RETURNED FOR EVAL, WE ARE UNABLE TO CONFIRM ANY MALFUNCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS. NO SPECIFIC FAILURE MODE WAS REPORTED. NO CONCLUSION REGARDING THE CUSTOMER'S HIGH BG'S CAN BE DRAWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WENT TO THE EMERGENCY ROOM IN RESPONSE TO "EXTREMELY HIGH" BG LEVELS. WHILE AT THE HOSPITAL THE POD WAS REMOVED, WHICH REVEALED AN INFECTION AT THE SITE. THE ER STAFF WAS "UNABLE TO DETERMINE IF IT WAS FROM THE POD OR NOT." THE CUSTOMER STATED THAT SHE CLEANS THE SITE WITH ALCOHOL SWABS AND/OR ALCOHOL AND COTTON SWABS, BUT IS UNSURE HOW IT WAS CLEANED PRIOR TO THE APPLICATION OF THE SUBJECT POD. SHE INDICATED THAT THIS WAS "THE SECOND TIME A POD HAS LEFT THERE INFECTED." THE METHOD OF TREATMENT OF THE INFECTION WHILE AT THE ER WAS NOT PROVIDED. THE POD WILL NOT BE RETURNED FOR EVAL. NOTE: THE CUSTOMER'S ENDOCRINOLOGIST STATED THAT "THE INFECTION COULD HAVE STOPPED THE FLOW OF INSULIN" AND LED TO THE HIGH BG LEVELS. SHE LEFT THE HOSPITAL AFTER 4.5 HOURS; A NEW POD WAS APPLIED TO TREAT THE HIGH BG'S. SHE WAS "FEELING A LITTLE SICK BUT IS GETTING BETTER."

    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 17 YR Hospitalization