BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2112368 · Received May 25, 2011

    Report

    Report Number
    3004464228-2011-00229
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    INSULET CORP
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POD WILL NOT BE RETURNED FOR EVAL - WE ARE UNABLE TO CONFIRM ANY DEVICE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS. NO TIME LINE OF THE EVENT WAS PROVIDED IN THE REPORT - IT THEREFORE UNK WHEN THE CANNULA HAD "COME OUT" OF HER SKIN IN RELATION TO WHEN HER BG LEVELS BEGAN TO RISE. NO CONCLUSION CAN BE DRAWN. THE OMNIPOD SYSTEM USER GUIDE WARNS: "CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. IT IS ALSO A GOOD IDEA TO CHECK YOUR BLOOD GLUCOSE ABOUT TWO HOURS AFTER EACH POD CHANGE AND TO CHECK THE INFUSION SITE PERIODICALLY. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT." THE CUSTOMER FOLLOWED USER GUIDE INSTRUCTIONS BY IMMEDIATELY REMOVING AND REPLACING THE POD UPON NOTICING THAT THE CANNULA WAS NOT INSERTED INTO HER SKIN. INSULET CUSTOMER SUPPORT HAD DIRECTED THE CUSTOMER TO THE OMNIPOD WEBSITE, WHICH INCLUDES A RESOURCE GUIDE THAT LISTS PRODUCTS THAT CAN AID IN POD ADHESION (WHICH COULD HELP TO KEEP THE POD MORE FIRMLY IN PLACE, MITIGATING THE RISK OF THE CANNULA PULLING FROM THE INSERTION SITE). A REVIEW OF LOT QUALIFICATION RECORDS WAS PERFORMED AND THE LOT PASSED THE ACCEPTANCE CRITERIA. (NOTE: EVAL METHOD CODES ARE SPECIFIC TO ACTIVITIES PERFORMED DURING LOT QUALIFICATION, NOT TO ACTIVITIES PERFORMED ON THE SUBJECT POD AS IT WILL NOT BE RETURNED FOR EVAL).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE "CANNULA WAS COMING OUT" OF HER SKIN AND, AS A RESULT, SHE "ENDED UP WITH HIGH BG'S." SHE "DOES NOT LIKE THE FACT THAT THERE IS NO ALARM TO WARN HER THE CANNULA IS COMING OUT." AFTER A BG LEVEL OF 355MG/DL, HER LEVELS ROSE TO 454MG/DL (NO TIME LINE OF THE EVENT WAS PROVIDED). SHE HAD REMOVED AND REPLACED THE POD AND IS "ALRIGHT NOW". THIS INCIDENT IS ONE OF "A COUPLE OF PROBLEMS WITH THE CANNULA COMING OUT" THAT THE CUSTOMER HAS EXPERIENCED. INSULET CUSTOMER SUPPORT REVIEWED POD PLACEMENT SUGGESTIONS WITH HER AND RECOMMENDED THAT SHE VISITS THE OMNIPOD WEBSITE FOR A LISTING OF PRODUCTS THAT CAN HELP TO KEEP THE DEVICE BETTER ADHERED TO HER BODY. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORP 11200 L30419

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other