BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 7731333 · Received July 30, 2018

    Report

    Report Number
    3004464228-2018-04761
    Event Type
    Death
    Date Received
    July 30, 2018
    Date of Event
    June 6, 2018
    Report Date
    July 2, 2018
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED DEATH. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE HUSBAND REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2018 DUE TO A MASSIVE HEART ATTACK. SHE WAS SUBSTITUTING FOR A SUMMER SCHOOL TEACHER AND STARTED TO COMPLAIN OF SHARP PAIN ALONG ONE OF HER SIDES. THE EMT (EMERGENCY MEDICAL TECHNICIAN) WAS CALLED AND SHE WENT INTO CARDIAC ARREST WHILE IN THE AMBULANCE, THE PATIENT WAS DECEASED ON ARRIVAL. HER HUSBAND STATED THAT SHE EXPERIENCED HIGH BLOOD PRESSURE AND SHE WAS TAKING MEDICATION FOR HYPERTENSION. THE HUSBAND DOES NOT REMEMBER IF THE PATIENT WAS WEARING A POD AT THE TIME AND DID NOT HAVE ACCESS TO THE PDM (PERSONAL DIABETES MANAGER), HE DID NOT KNOW WHERE IT WAS LOCATED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. THE HUSBAND STATED HE WOULD SEND A COPY OF THE PATIENT'S DEATH CERTIFICATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574902 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death