BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1780868 · Received July 29, 2010

    Report

    Report Number
    3004464228-2010-01209
    Event Type
    Injury
    Date Received
    July 29, 2010
    Date of Event
    June 26, 2010
    Report Date
    July 2, 2010
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED WILL NOT BE RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE PRODUCT USER GUIDE INSTRUCTS USERS TO CHECK BLOOD GLUCOSE LEVELS FREQUENTLY, SO THAT THEY'RE ABLE TO NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES. THE USER GUIDE ALSO SUGGESTS THAT THE PT ALWAYS CARRY EXTRA SUPPLIES IN CASE OF AN EMERGENCY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE EXPERIENCED BG'S THAT "WERE HIGH AND SHE DID NOT KNOW WHY"; HER LEVELS RANGED FROM 264-340 MG/DL OVER A SIX HOUR PERIOD AND "WOULD NOT COME DOWN". AS A RESULT, SHE WENT TO THE HOSPITAL AND WAS ADMITTED FOR DKA. AFTER RUNNING TESTS ON THE CUSTOMER, THE MEDICAL STAFF ATTRIBUTED HER CONDITION "TO HER PUMP". WHILE IN THE HOSPITAL, THE POD INITIATED AN OCCLUSION ALARM. THE POD WAS DISCARDED AT THE HOSPITAL AND WILL THEREFORE NOT BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30317

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention