BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2831002 · Received November 2, 2012

    Report

    Report Number
    3004464228-2012-00551
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 4, 2012
    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 TO DETERMINE IF ANY MALFUNCTION OR MANUFACTURING DEFECT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE ARE SAFETY MECHANISMS IN THE DESIGN OF THE POD TO PREVENT OVER-DELIVERY OF INSULIN THAT CONTRIBUTES TO HYPOGLYCEMIA. NO QUALIFICATION RECORD REVIEW COULD BE PERFORMED AS NO PRODUCT LOT NUMBER WAS REPORTED. THE OMNIPOD USER'S GUIDE WARNS "TEST RESULTS BELOW 70 MG/DL MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA). IF YOU GET RESULTS BELOW 70 MG/DL, BUT DO NOT HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 70 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER," AND ADVISE "HYPOGLYCEMIA CAN OCCUR EVEN WHEN A POD IS WORKING PROPERLY. NEVER IGNORE THE SIGNS OF LOW BLOOD GLUCOSE (NO MATTER HOW MILD). IF LEFT UNTREATED, SEVERE HYPOGLYCEMIA CAN CAUSE SEIZURES OR LEAD TO UNCONSCIOUSNESS. IF YOU SUSPECT THAT YOUR BLOOD GLUCOSE LEVEL IS LOW, CHECK YOUR BG LEVEL TO CONFIRM."

    Description of Event or Problem · 1

    AN INSULET TERRITORY MANAGER REPORTED THAT A PATIENT WAS HOSPITALIZED LAST WEEK WITH SEVERE HYPOGLYCEMIA. HIS BLOOD GLUCOSE WAS MEASURED AT 19 MG/DL UPON ADMISSION. THREE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER, ENSURE THAT HE HAD RECOVERED, AND GATHER ADDITIONAL INFORMATION ABOUT THE INCIDENT. HE DID NOT RESPOND TO MESSAGES.

    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 36 YR Hospitalization