BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3041983 · Received March 29, 2013

    Report

    Report Number
    3004464228-2013-00283
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    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 DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED METABOLIC OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED METABOLIC DERANGEMENT AND HOSPITALIZATION. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS A PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    A HOSPITAL NURSE PRACTITIONER CALLED TO ASK HOW TO REMOVE A POD FROM A PATIENT WHO WAS HOSPITALIZED WITH METABOLIC DERANGEMENT. IT WAS NOT KNOWN IF HIS CONDITION WAS RELATED TO WEARING THE POD. NO OTHER DETAILS WERE PROVIDED AS TO THE CUSTOMER'S TREATMENT OR BLOOD GLUCOSE HISTORY, AND THE NURSE PRACTITIONER DID NOT HAVE THE PDM AVAILABLE AT THE TIME OF THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130644 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization