BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1031236 · Received April 17, 2008

    Report

    Report Number
    3004464228-2008-00029
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 16, 2008
    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

    THE DEVICE INVOLVED HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AS OF THE REPORT DATE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE PRODUCT IS SUBSEQUENTLY RECEIVED. UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE PRODUCT USER GUIDE INSTRUCTS THE USER TO 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

    WIFE CALLED FOR HUSBAND TO REPORT THAT HE WENT TO THE EMERGENCY ROOM WITH HIS BG AT 740. HE WAS ADMITTED AND TREATED FOR HYPERGLYCEMIA. SHE REPORTED THAT IN THE ER, THE POD WAS PLACED IN A BIOHAZARD BOX FOR DISPOSAL. SHE SUBSEQUENTLY WAS ABLE TO GET THE POD FROM THE HOSPITAL FOR RETURN AND EVALUATION. SHE ALSO REPORTED THAT SHE WAS UPSET ABOUT THE TRAINING HE RECEIVED AS WELL. FELT THEY WERE NOT INSTRUCTED WELL ABOUT SICK DAYS AND HOSPITAL STAYS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11519

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization