BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2251791 · Received August 31, 2011

    Report

    Report Number
    3004464228-2011-00550
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 6, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POD WAS NOT RETURNED FOR EVALUATION - WE ARE UNABLE TO IDENTIFY ANY DEVICE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS. NO MECHANICAL ISSUE CAN BE CONFIRMED. IF THE CANNULA HAD PULLED OUT OF THE SKIN AS THE CUSTOMER STATED THEY OBSERVED, THIS WOULD HAVE INTERRUPTED INSULIN DELIVERY AND CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. 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." BASED ON THE INFORMATION PROVIDED IN THE REPORT, IT IS UNKNOWN WHEN THE CANNULA HAD PULLED OUT FROM THE INSERTION SITE IN RELATION TO WHEN BG LEVELS BEGAN TO INCREASE. A REVIEW OF LOT QUALIFICATION RECORDS WAS PERFORMED - THE LOT PASSED THE ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AND WAS "SLURRING HIS WORDS" AND "FEELING KIND OF BAD" - HE WAS INTO HIS THIRD DAY OF POD WEAR AND HAD EXPERIENCED A HIGH BG LEVEL "AROUND 300MG/DL." HE STATED THAT THE CANNULA "WAS OUT OF THE SKIN" (THOUGH NO REASON AS TO HOW THE CANNULA HAD BECOME DISPLACED WAS PROVIDED). HE REQUESTED THAT INSULET PRODUCT SUPPORT "STAY ON THE PHONE WHILE HE FILLS A NEW POD AND PUTS IT ON." PRODUCT SUPPORT ADVISED HIM TO CHECK HIS LEVELS IN AN HOUR TO MAKE SURE THAT HIS BG'S WERE GOING DOWN. THE POD WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSON, INSULIN LZG INSULET CORPORATION 11200 L30579

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other