BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1780867 · Received July 29, 2010

    Report

    Report Number
    3004464228-2010-01207
    Event Type
    Injury
    Date Received
    July 29, 2010
    Date of Event
    June 26, 2010
    Report Date
    June 29, 2010
    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 POD WILL NOT BE RETURNED FOR EVAL. UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. THE OMNIPOD USER GUIDE INSTRUCTS PTS TO CHECK THE INFUSION SITE DAILY FOR SIGNS OF INFECTION SUCH AS PAIN, SWELLING, REDNESS, DISCHARGE OR HEAT. IF THERE ARE SIGNS THAT THE SITE MAY BE INFECTED, THE PT IS ADVISED TO IMMEDIATELY REMOVE THE POD AND APPLY A NEW ONE, CONTACT A HEALTHCARE PROVIDER AND TREAT THE INFECTION ACCORDING TO THE HEALTH CARE PROVIDER'S INSTRUCTIONS. THE CUSTOMER FOLLOWED THESE INSTRUCTIONS PER THE USER GUIDE AND WAS GIVEN ANTIBIOTICS TO TREAT THE INFECTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HIS BG'S WERE "RISING ALL DAY"; AFTER A "HIGH" READING (GREATER THAN 500MG/DL), HE WENT TO THE ER. WHILE AT THE HOSPITAL, HIS BG LEVEL WAS AGAIN TAKEN, WHICH READ 609MG/DL. DURING THIS TIME THE CUSTOMER WAS ON ANTIBIOTICS TO TREAT A SKIN INFECTION THAT RESULTED FROM WEARING A POD; THE CUSTOMER'S DOCTOR BELIEVED THE HIGH BG'S "COULD POSSIBLY HAVE BEEN FROM THE ANTIBIOTICS". THE DOCTOR ADMINISTERED AN IV TO TREAT THE HIGH BG'S AND RECOMMENDED THAT THE POD CONTINUE TO BE WORN (BUT NO INSULIN INJECTION SHOULD BE ADMINISTERED AT THIS TIME). AFTER 6.5 HOURS, THE CUSTOMER WAS RELEASED FROM THE HOSPITAL. THE POD WAS DISCARDED AND WILL THEREFORE NOT BE 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 UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention