BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3143082 · Received May 29, 2013

    Report

    Report Number
    3004464228-2013-00508
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 28, 2013
    Report Date
    April 29, 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 RETURNED DEVICE WAS EVALUATED AND PERFORMED AS DESIGNED. NO MALFUNCTION OR OTHER PRODUCT CONDITION WAS FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA AND EMERGENCY ROOM VISIT. FLUID WAS OBSERVED EXITING THE DISTAL TIP OF THE CANNULA, INDICATING NO INTERNAL OCCLUSION. LOT QUALIFICATIONS RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. 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" AND "IF YOUR READING IS ABOVE 500 MG/DL, THE PDM DISPLAYS 'HIGH CHECK FOR KETONES!' THIS INDICATES SEVERE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE). IF YOU GET A 'HIGH CHECK FOR KETONES!' READING AND FEEL SYMPTOMS SUCH AS FATIGUE, THIRST, EXCESS URINATION, OR BLURRY VISION, FOLLOW YOUR HEALTHCARE PROVIDER'S RECOMMENDATION TO TREAT HYPERGLYCEMIA." IT ADVISES, "IF YOUR BLOOD GLUCOSE IS 250 MG/DL OR ABOVE, CHECK FOR KETONES. IF KETONES ARE PRESENT, FOLLOW YOUR HEALTHCARE PROVIDER'S GUIDELINES. IF KETONES ARE NOT PRESENT, TAKE A CORRECTION BOLUS AS PRESCRIBED BY YOUR HEALTHCARE PROVIDER. CHECK BLOOD GLUCOSE AGAIN AFTER 2 HOURS. IF BLOOD GLUCOSE LEVELS HAVE NOT DECREASED, TAKE A SECOND BOLUS BY INJECTION, USING A STERILE SYRINGE. IF YOU FEEL NAUSEATED AT ANY POINT, CHECK FOR KETONES AND CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY. IF BLOOD GLUCOSE REMAINS HIGH AFTER ANOTHER 2 HOURS (A TOTAL OF 4 HOURS), REPLACE THE POD."

    Description of Event or Problem · 1

    THE PATIENT'S HUSBAND REPORTED THAT HIS WIFE WENT TO THE EMERGENCY ROOM FOR HYPERGLYCEMIA AND VOMITING. HE STATED THAT HER POD WAS ACTIVATED ON (B)(6) AT 11:50AM. HE PROVIDED THE FOLLOWING BLOOD GLUCOSE HISTORY. AT 8:59AM, HER RESULT WAS "HIGH" (>500 MG/DL). SHE GAVE HERSELF A 5U BOLUS AT 9:13AM. SHE WAS VOMITING, SO SHE WENT TO THE EMERGENCY ROOM. AT 11:03AM, THE POD WAS REMOVED IN THE HOSPITAL. THERE, THEY NOTICED A DRIED BLOOD CLOT IN THE CANNULA. SHE WAS GIVEN MEDICATION TO STOP THE VOMITING, AND SHE WAS PUT ON INTRAVENOUS FLUIDS AND AN INTRAVENOUS DRIP. WHEN SHE WAS RELEASED FROM THE HOSPITAL, HER BLOOD GLUCOSE LEVEL WAS 102 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235828 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31029

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other