BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMINIPOD INSULIN PUMP

    MDR report key: 3926199 · Received July 1, 2014

    Report

    Report Number
    3004464228-2014-00911
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA AND HOSPITALIZATION. NO PRODUCT LOT NUMBER WAS REPORTED THEREFORE NO QUALIFICATION RECORDS WERE REVIEWED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT ON (B)(6) 2014 HER BLOOD GLUCOSE AND INSULIN HISTORY IS AS FOLLOWS: SHE WOKE UP THIS MORNING FEELING SICK AND WAS LATER FOLLOWED BY CHEST PAIN LIKE SHE WAS HAVING A HEART ATTACK SO SHE CALLED FOR AN AMBULANCE. UPON THEIR ARRIVAL SHE WAS RUSHED TO THE HOSPITAL AND THEY PLACED HER ON AN INTRAVENOUS DRIP OF INSULIN, FLUIDS, MORPHINE AND SHE WAS ALSO GIVEN BLOOD THINNER. THE POD WAS REMOVED AND DISCARDED BY THE HOSPITAL STAFF. HER DIAGNOSIS WAS UNDETERMINED AT THE TIME OF THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382177 OMINIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization