BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3131314 · Received May 17, 2013

    Report

    Report Number
    3004464228-2013-00463
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 19, 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 DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA AND HOSPITALIZATION FOR DIABETIC KETOACIDOSIS. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS A PRODUCT LOT NUMBER WAS NOT PROVIDED. THE OMNIPOD USER GUIDE WARNS, "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER." IT ADVISES, "ONCE YOU HAVE BEGUN TREATMENT FOR HIGH BLOOD GLUCOSE, CHECK FOR KETONES. CHECK FOR KETONES ANY TIME YOUR BLOOD GLUCOSE IS 250 MG/DL OR ABOVE. IF KETONES ARE NEGATIVE OR TRACE, CONTINUE TREATING FOR HIGH BLOOD GLUCOSE. IF KETONES ARE PRESENT, AND YOU ARE FEELING NAUSEATED OR ILL, IMMEDIATELY CALL YOUR HEALTHCARE PROVIDER FOR GUIDANCE. IF KETONES ARE POSITIVE, BUT YOU ARE NOT FEELING NAUSEATED OR ILL, REPLACE THE POD, USING A NEW VIAL OF INSULIN. CHECK BLOOD GLUCOSE AGAIN AFTER 2 HOURS. IF BLOOD GLUCOSE LEVEL HAS NOT DECLINED, IMMEDIATELY CALL YOUR HEALTHCARE PROVIDER FOR GUIDANCE."

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HIS BLOOD GLUCOSE WAS IN THE NORMAL RANGE IN THE MORNING OF (B)(6) 2013. AT 3:00 PM, HIS BLOOD GLUCOSE RESULT WAS 375 MG/DL. HE STATED THAT IT CONTINUED TO RISE, EVEN WHEN HE GAVE HIMSELF BOLUSES. THE HIGHEST READING OF THE DAY WAS 484 MG/DL. HE SAID THAT HE WENT TO THE HOSPITAL AT 5:30 AM ON (B)(6) IN DIABETIC KETOACIDOSIS AND WAS ADMITTED. THE HOSPITAL REMOVED THE POD, AND HE WAS GIVEN INSULIN. THE POD WAS DISCARDED. HE WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220142 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization