BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2071851 · Received April 25, 2011

    Report

    Report Number
    3004464228-2011-00178
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 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 DEVICE IS NOT EXPECTED TO RETURN TO THE MFR FOR EVAL. WE ARE UNABLE TO CONFIRM ANY MALFUNCTION OR PRODUCT CONDITION THAT MAY HAVE CONTRIBUTED TO INTERRUPTED OR RESTRICTED INSULIN FLOW, RESULTING IN INEFFECTIVE BOLUS ATTEMPTS. THE CUSTOMER DID NOT OBSERVE ANY SPECIFIC FAILURE MODE. NO CONCLUSION CAN BE DRAWN AS TO WHETHER A DEVICE MALFUNCTION CONTRIBUTED TO THE CUSTOMER'S HIGH BLOOD GLUCOSE. THE OMNIPOD USER'S GUIDE INSTRUCTS CUSTOMERS TO "REPLACE THE POD" AND "CONTACT YOUR HEALTHCARE PROVIDER FOR GUIDANCE" IF BLOOD GLUCOSE LEVELS REMAIN HIGH FOUR HOURS AFTER A BOLUS IS FIRST ADMINISTERED. A REVIEW OF LOT QUALIFICATION RECORDS WAS NOT POSSIBLE BECAUSE NO DEVICE LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE CHANGED THE DEVICE AS SCHEDULED AND ONCE THE NEW POD WAS PLACED, HER BLOOD GLUCOSE BEGAN TO RISE (NO SPECIFIC TIMES OR READINGS REPORTED). CUSTOMER DELIVERED SUGGESTED BOLUSES BASED ON HER ENTRIES INTO THE PERSONAL DIABETES MANAGER (SPECIFIC TIMES AND DOSAGES NOT REPORTED). SHE REPORTED HER BLOOD GLUCOSE WAS BETWEEN 300 AND 399 MG/DL. CUSTOMER NOTED THAT HER BLOOD GLUCOSE WAS NOT RESPONDING TO HER BOLUS AND WENT TO THE EMERGENCY ROOM. UPON ARRIVAL, BLOOD GLUCOSE WAS 489MG/DL AND THEN 500 MG/DL. CUSTOMER WAS PLACED ON AN INSULIN DRIP WHILE IN THE EMERGENCY ROOM AND THE POD WAS REMOVED. CUSTOMER NO LONGER HAS POD BUT NOTED THERE WAS NO ALARM. SHE STATED THE CANNULA WAS NOT KINKED OR PULLED OUT, NOR DID SHE OBSERVE ANY BLOOD IN THE CANNULA.

    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 21 YR Hospitalization