BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 863564 · Received June 8, 2007

    Report

    Report Number
    3004464228-2007-00063
    Event Type
    Other
    Date Received
    June 8, 2007
    Date of Event
    May 6, 2007
    Report Date
    June 8, 2007
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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 NORMAL OPERATION AND 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 PATIENT'S ELEVATED BLOOD GLUCOSE LEVELS. THE PRODUCT USER GUIDE INSTRUCTS THE USER TO "CHECK 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 CALLED FOR DAUGHTER WHO USES THE OMNIPOD SYSTEM. SHE STATED THAT HER DAUGHTER HAD BEEN HOSPITALIZED FOR HYPOGLYCEMIA AND DKA. HER BG LEVELS DURING THE EVENT RANGED FROM 298 TO OVER 500. CALLER STATED THEY BROUGHT THEIR DAUGHTER TO THE HOSP AT 3PM IN 2007. ALSO THAT DURING THESE PERIODS OF HIGH BG, SHE WAS WITH HER FATHER AND HE HAD BEEN GIVING HER MANUAL INJECTIONS OF INSULIN AFTER 1PM, HOWEVER, SHE WAS NOT AWARE OF THE DOSES OR WHEN THEY WERE GIVEN. ONCE SHE ARRIVED AT THE HOSP, THE POD WAS REMOVED. THE DEVICE IS BEING RETURNED TO THE MANUFACTURER FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11032

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| O