BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3981446 · Received July 24, 2014

    Report

    Report Number
    3004464228-2014-01056
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 27, 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 THE PRODUCT MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA AND HOSPITALIZATION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED ON (B)(6) 2014 AT 6:00 AM HER DAUGHTER ACTIVATED A NEW POD AND AFTER WEARING THE POD FOR LESS THAN 3 HOURS SHE STARTED TO FEEL SICK AND WAS VOMITING. SHE GOT HOME AT 4:00 PM AND CALLED HER DOCTOR WHO ADVISES HER TO GIVE A BOLUS OF INSULIN (EXACT DOSAGE WAS NOT PROVIDED) AND GO TO THE EMERGENCY ROOM. HER BLOOD GLUCOSE WAS READING "HIGH" (>500 MG/DL) AND UPON ARRIVAL AT THE EMERGENCY ROOM HER BG REACHED OVER 1000 MG/DL WITH THE HOSPITAL METER. SHE WAS TAKEN TO THE CRITICAL CARE AND THEN TO THE INTENSIVE CARE UNIT. THEY PACED HER ON AN INTRAVENOUS THERAPY, ELECTROCARDIOGRAM (EKG) AND TOOK SOME CHEST X-RAYS. THE POD WAS REMOVED AT THE HOSPITAL AFTER 38 HOURS OF POD WEAR. HER BG WAS READING 180 MG/DL BEFORE BEING RELEASED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435212 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40897

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization