BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3364689 · Received September 19, 2013

    Report

    Report Number
    3004464228-2013-01086
    Event Type
    Injury
    Date Received
    September 19, 2013
    Date of Event
    August 19, 2013
    Report Date
    August 23, 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 EVAL. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE PT'S DIABETIC KETOACIDOSIS AND HOSPITALIZATION. NO PRODUCT LOT NUMBER WAS REPORTED THEREFORE NO QUALIFICATION RECORDS COULD BE REVIEWED. THE OMNIPOD USER GUIDE ADVISES "THE EASIEST AND MOST RELIABLE WAY TO AVOID DKA IS BY CHECKING YOUR BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY. ROUTINE CHECKS ALLOW YOU TO IDENTIFY AND TREAT HIGH BLOOD GLUCOSE BEFORE DKA DEVELOPS," AND "WHEN YOU ARE ILL, CHECK YOUR BLOOD GLUCOSE MORE OFTEN (AT LEAST ONCE EVERY 2 HOURS) TO AVOID DKA. THE SYMPTOMS OF DKA ARE MUCH LIKE THOSE OF THE FLU. BEFORE ASSUMING YOU HAVE THE FLU, CHECK YOUR BLOOD GLUCOSE TO RULE OUT DKA."

    Description of Event or Problem · 1

    THE PT REPORTED THAT SHE WAS ADMITTED TO THE HOSPITAL DUE TO AN ILLNESS, BUT ALSO WAS IN DIABETIC KETOACIDOSIS. SHE BELIEVED THE DKA WAS DUE TO THE ILLNESS RATHER THAN TO ANY ISSUE WITH THE DEVICE AND DID NOT GIVE ANY HISTORY LEADING UP TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474236 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization