BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3122531 · Received May 16, 2013

    Report

    Report Number
    3004464228-2013-00452
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 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 EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE PATIENT'S HYPERGLYCEMIA, DIABETIC KETOACIDOSIS AND HOSPITALIZATION. NO QUALIFICATION RECORDS COULD BE REVIEWED BECAUSE NO PRODUCT LOT NUMBER WAS REPORTED. THE OMNIPOD USER GUIDE WARNS "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA)," AND "IF LEFT UNTREATED, DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, AND EVENTUALLY DEATH." 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 YOUR 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

    AN INSULET CLINICAL SERVICES MANAGER REPORTED THAT A PATIENT WAS HOSPITALIZED FOR HYPERGLYCEMIA, BUT HAD NO FURTHER INFORMATION TO PROVIDE. A CALL WAS MADE TO THE PATIENT TO GATHER INFORMATION BUT SHE WAS UNAVAILABLE. A MESSAGE WAS LEFT ASKING HER TO CALL BACK WHEN SHE IS BETTER. A CALL WAS RECEIVED FROM (B)(6), THE (B)(6) AT (B)(6) HOSPITAL REPORTING THAT THE PATIENT HAD ACTUALLY BEEN ADMITTED FOR DIABETIC KETOACIDOSIS AND DID NOT WANT TO REMOVE THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216870 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization