BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3853350 · Received May 27, 2014

    Report

    Report Number
    3004464228-2014-00716
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 26, 2014
    Report Date
    April 29, 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 DEVICE 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 ER VISIT. NO PRODUCT LOT NUMBER WAS REPORTED THEREFORE NO QUALIFICATION RECORDS WERE REVIEWED.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED WHILE HER DAUGHTER WAS AT SCHOOL, SHE VOMITED AT LEASE TWO TIMES AND HER BLOOD GLUCOSE AND INSULIN HISTORY IS AS FOLLOWS: TIME: UNKNOWN TIME, BG (MG/DL): 127, BOLUS (U): NONE. TIME: 1:00 AM, BG (MD/GL): 'HIGH' (>500) AND 515 (ALTERNATE METER), BOLUS (U): CALLED DOCTOR WHO ADVISED 9.0 (MANUAL INJECTION). SHE STARTED TO VOMIT AGAIN AND HER BG WAS READING 600 MG/DL. SHE WAS THEN TAKEN TO THE EMERGENCY ROOM. UPON ARRIVAL SHE PLACED ON AN INTRAVENOUS DRIP OF FLUIDS AND INSULIN. HER KETONE RESULT WAS LOW AT THE HOSPITAL SO SHE HAD TO BE TESTED EVERY HOUR. ATTEMPTS WERE MADE TO CONTACT THE PATIENT'S MOTHER TO PROVIDE ADDITIONAL INFORMATION. MESSAGES WERE LEFT, BUT SHE DID NOT RETURN THE CALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311776 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other