BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4213649 · Received September 26, 2014

    Report

    Report Number
    3004464228-2014-01447
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 1, 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 CONFIRM THE REPORTED KINKED CANNULA OR TO DETERMINE WHETHER IT CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA OR HOSPITALIZATION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ON (B)(6) 2014 HER BLOOD GLUCOSE MEASURED 147 MG/DL AT 4:20 PM, 465 MG/DL AT 7:30 PM, AND 330 MG/DL (WITH KETONES 3+) AT 9:30 PM WITH NO BOLUSES REPORTED. SHE WAS VOMITING AND DECIDED TO GO TO THE CITY HOSPITAL OF NETTETAL. SHE NOTICED THE CANNULA WAS KINKED AND THE ADHESIVE PAD WAS WET. SHE WAS IN THE HOSPITAL FOR A WEEK BEFORE BEING RELEASED. SHE DID NOT PROVIDE ANY FURTHER INFORMATION REGARDING THE HOSPITALIZATION OR HER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599867 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810-5E L40935

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization