BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2137465 · Received June 20, 2011

    Report

    Report Number
    3004464228-2011-00297
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 20, 2011
    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

    NO PRODUCT WILL BE RETURNED FOR EVAL - WE ARE UNABLE TO CONFIRM ANY POD "ERRORS" THAT MAY HAVE CAUSED OR CONTRIBUTED TO A HYPO- OR HYPERGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. NO SPECIFIC POD ISSUES WERE NOTED IN THE REPORT. BASED ON THE INFO PROVIDED AND IN THE ABSENCE OF A DEVICE EVAL, WE CANNOT CONFIRM THAT A POD MALFUNCTION WAS A CONTRIBUTING FACTOR TO THE ER VISITS. NO CONCLUSION CAN BE DRAWN. NO POD LOT NUMBER WAS PROVIDED - A REVIEW OF LOT QUALIFICATION RECORDS WAS THEREFORE UNABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT HER SON IS NOW OFF THE OMNIPOD SYSTEM DUE TO "A HIGH NUMBER OF ERRORS." (NO SPECIFIC POD FAILURES WERE REPORTED, HOWEVER.) AS A RESULT OF THE POD ERRORS, HE "HAD ENDED UP IN THE ER A COUPLE TIMES." BECAUSE OF THE MOTHER'S "THICK ACCENT", INSULET CUSTOMER SUPPORT WAS UNABLE TO OBTAIN ANY ADDITIONAL INFO ABOUT THE ISSUES THAT WERE EXPERIENCED WITH THE SYSTEM OR ABOUT THE HOSPITAL EVENTS. NO PRODUCT WILL 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 20 YR Required Intervention