BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3030595 · Received March 21, 2013

    Report

    Report Number
    3004464228-2013-00246
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 20, 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 RETAINED AND WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE PATIENT'S HYPERGLYCEMIA AND EMERGENCY ROOM VISIT. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS "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." AND "HIGH BLOOD GLUCOSE READINGS CAN INDICATE A POTENTIALLY SERIOUS CONDITION REQUIRING IMMEDIATE MEDICAL ATTENTION. IF LEFT UNTREATED, THIS SITUATION CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA), SHOCK, COMA, OR DEATH." IT ADVISES "TO AVOID HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) CHECK YOUR BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY (WHEN YOU WAKE UP, BEFORE EACH MEAL, AND BEFORE GOING TO BED)," AND "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 BLOOD GLUCOSE REMAINS HIGH AFTER ANOTHER 2 HOURS (A TOTAL OF 4 HOURS), REPLACE THE POD."

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HER BLOOD GLUCOSE WAS 166 MG/DL AT 7:10 AM, BUT ROSE TO "HIGH" (>500 MG/DL) BY 2:09 PM. SHE WAS HAVING ABOUT 32 GRAMS OF CARBOHYDRATE AND TOOK A 17 UNIT BOLUS FOR CORRECTION AND THE MEAL. AT 7:45 PM HER BG REMAINED "HIGH," SHE WAS EATING 30 GRAMS OF CARBOHYDRATE AND BOLUSED ANOTHER 16.5 UNITS. AT 7:54 PM SHE RECEIVED A "LOW RESERVOIR" ALERT AND DEACTIVATED THE POD AT 8:40 PM. ANOTHER POD WAS ACTIVATED AT 8:47 PM, BUT HER BG REMAINED "HIGH" AT 9:27 PM. HER CDE ADVISED HER TO GO TO THE EMERGENCY ROOM. SHE LEFT FOR THE E.R. SHORTLY AFTER 10:08 PM WHEN HER BG WAS STILL "HIGH" AND SHE WAS SHOWING KETONES. THE POD WAS REMOVED AT THE E.R. AND SHE WAS GIVEN AN INJECTION OF 8 UNITS OF HUMULIN. SHE ALSO RECEIVED IV FLUIDS. SHE LEFT THE E.R. AROUND 2:00 AM ON (B)(6). SHE NO LONGER HAS THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117048 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31019

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other