BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2111802 · Received May 26, 2011

    Report

    Report Number
    3004464228-2011-00233
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    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 PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE PRODUCT CONDITION OR ANY MALFUNCTION THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S HIGH BLOOD GLUCOSE AND HOSPITALIZATION. NO CONCLUSION CAN BE DRAWN. LOT QUALIFICATION RECORDS COULD NOT BE REVIEWED BECAUSE NO DEVICE LOT NUMBER WAS PROVIDED. THE COMPLAINT RATE FOR THE REPORTED SYMPTOM IS BELOW THE ESTABLISHED ALERT LIMIT. THE OMNIPOD USER'S GUIDE RECOMMENDS FREQUENT MONITORING OF BLOOD GLUCOSE TO DETECT AND REACT TO PROBLEMS IN A TIMELY AND APPROPRIATE MANNER, INCLUDING TO REMOVE AND REPLACE THE DEVICE AFTER NO MORE THAN FOUR HOURS AFTER ATTEMPTING TO CORRECT A HYPERGLYCEMIC CONDITION IF BLOOD SUGAR REMAINS ELEVATED.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CALLED FROM THE HOSPITAL. PATIENT WAS ADMITTED WITH HIGH BLOOD GLUCOSE (NO SPECIFIC MEASUREMENTS REPORTED). THE CALLER STATED THAT THE DEVICE SEEMED TO NOT BE DELIVERING INSULIN. SHE DIDN'T SPECIFY WHETHER THE DEVICE USED PRIOR TO THE HOSPITALIZATION WAS STILL AVAILABLE TO BE RETURNED FOR INVESTIGATION. THE MOTHER ALSO REPORTED THAT AFTER HOSPITAL STAFF HAD GOTTEN HER DAUGHTER'S BLOOD GLUCOSE LEVELS STABLE AND NORMAL AFTER 4 DAYS, THEY PLACED A NEW DEVICE AND AFTER ABOUT 3 HOURS HER BLOOD GLUCOSE LEVELS ELEVATED AGAIN. THE CALLER ALSO REPORTED THAT THE PATIENT IS UNWILLING TO ROTATE WEARING OF THE DEVICE TO SITES OTHER THAN THE ABDOMEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization