BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1903492 · Received November 16, 2010

    Report

    Report Number
    3004464228-2010-01371
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 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 INVOLVED WILL NOT BE RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE OMNIPOD USER GUIDE INSTRUCTS USERS TO CHECK BLOOD GLUCOSE LEVELS FREQUENTLY, SO THEY'RE ABLE TO NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES. THE USER GUIDE ALSO ADVISES THAT, IF BG LEVELS REMAIN HIGH FOUR HOURS AFTER A BOLUS WAS FIRST ADMINISTERED, THEN THE POD SHOULD BE REPLACED AND A HEALTHCARE PROVIDER SHOULD BE CONTACTED FOR GUIDANCE.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT HER DAUGHTER'S BG LEVELS "WENT UP AS HIGH AS 490 MG/DL" AND, AS A RESULT, SHE WAS TAKEN TO THE ER. THE REPORT INDICATED THAT "SEVERAL" BOLUSES HAD BEEN ADMINISTERED PRIOR TO HER HOSPITALIZATION, BUT HER BG LEVELS WOULD NOT COME DOWN. SHE WAS RELEASED FROM THE HOSPITAL WITHIN THREE HOURS. ONCE BACK AT HOME, A NEW POD WAS APPLIED AND HER LEVELS "WERE BROUGHT DOWN TO NORMAL". THE SUSPECT POD WAS DISCARDED AT THE HOSPITAL 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 13 YR Required Intervention