BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 855179 · Received May 24, 2007

    Report

    Report Number
    3004464228-2007-00057
    Event Type
    Other
    Date Received
    May 24, 2007
    Report Date
    April 24, 2007
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT WAS EVALUATED FOR DEFECTS. IT WAS DETERMINED THAT THERE WERE NO MECHANICAL OR ELECTRICAL DEFECTS THAT WOULD HAVE CAUSED THE DEVICE TO MALFUNCTION OR PREVENT INSULIN DELIVERY. NO OCCLUSION OR PULSE WIDTH TIME OUT'S WERE NOTED DURING REVIEW OF THE POD'S DOWNLOADED DATA. UNABLE TO DETERMINE POSSIBLE CAUSE OF PT'S ELEVATED BLOOD GLUCOSE LEVELS. THE PROD USER GUIDE INSTRUCTS THE USER TO "CHECK THE INFUSION SITE FREQUENTLY FOR PROPER CANNULA PLACEMENT". IT ALSO SUGGESTS THAT THE USER SHOULD CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY, SO THAT THEY CAN NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES.

    Description of Event or Problem · 1

    CUSTOMER SAID HER BG WAS HIGH AND SHE WASN'T SURE WHY. SHE SAID IT WAS OK UNTIL MIDDAY THEN IT STARTED GOING UP. HER BG READINGS RANGED FROM THE LOW 400'S TO 508. SHE COULDN'T REMEMBER WHY SHE CANCELLED THE FIRST BOLUS AT 4:45PM. SHE DIDN'T KNOW WHY SHE ADJUSTED THE 2ND BOLUS. SHE COULDN'T REMEMBER IF SHE ATE ANYTHING BETWEEN 12:30 PM AND 4PM. SHE DIDN'T ENTER ANY CARBS/MEAL BOLUS INFO AFTER 12:33PM BUT SHE DID SAY SHE HAD GONE TO A FRIENDS HOUSE FOR DINNER. SHE CALLED HER DOCTOR. SHE SPOKE TO AN ON-CALL DOCTOR WHO TOLD HER TO GO THE ER. WHEN SHE ARRIVED AT THE ER HER BG WAS 508. SHE WAS GIVEN 20U OF INSULIN AND ALSO SALINE. SHE WAS IN THE HOSPITAL FROM 11:30PM - 5:30AM. HER BG WHEN SHE WAS RELEASED FROM THE HOSPITAL WAS 177. SHE HAD NOT REMOVED HE POD WHILE SHE WAS IN THE HOSPITAL. SHE SAID THE DOCTOR IN THE ER WAS NOT FAMILIAR WITH THE POD NOR DID NE KNOW A LOT ABOUT DIABETES. WHEN SHE GOT HOME SHE SLEPT FOR A FEW HOURS. WHEN SHE WOKE UP SHE ATE. AT 11AM HER BG WAS 300. BY THE AFTERNOON HER BG WAS UP TO 400. SHE THEN CHANGED THE POD. THE DEVICE IS BEING RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L10880

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other