BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3940845 · Received July 7, 2014

    Report

    Report Number
    3004464228-2014-00939
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    INSULET CORP
    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 CONFIRM ANY PRODUCT MALFUNCTION OR OTHER PRODUCT CONDITION TO HAVE CONTRIBUTED TO THE PT'S HYPERGLYCEMIA AND HOSPITALIZATION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE PT REPORTED THAT AFTER WEARING THE POD FOR LESS THAN 24 HOURS, SHE WAS HOSPITALIZED WITH BLOOD GLUCOSE READING OF 20 MMOL/L (360 MG D/L) AND KETONES WERE 6.5. THEY TREATED HER WITH AN INFUSION OF NACL AND INSULIN. SHE STAYED IN THE HOSPITAL FOR A DAY BEFORE BEING RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393105 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORP 14810-5J L40802

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization