BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3162070 · Received May 30, 2013

    Report

    Report Number
    3004464228-2013-00517
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LFR
    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 REPORTED HYPOGLYCEMIA AND HOSPITALIZATION. NO QUALIFICATION RECORDS WERE REVIEWED BECAUSE NO PRODUCT LOT NUMBER WAS PROVIDED. THE OMNIPOD USER GUIDE WARNS, "IF YOU ARE UNABLE TO USE THE OMNIPOD INSULIN MANAGEMENT SYSTEM ACCORDING TO INSTRUCTIONS, YOU MAY BE PUTTING YOUR HEALTH AND SAFETY AT RISK. TALK WITH YOUR HEALTHCARE PROVIDER IF YOU HAVE QUESTIONS OR CONCERNS ABOUT USING THE OMNIPOD SYSTEM," 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 "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)."

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER CALLED FROM THE HOSPITAL, BUT DID NOT HAVE TIME TO GIVE ANY ADDITIONAL INFORMATION AT THIS TIME. SHE AGREED TO A CALL BACK LATER IN THE EVENING. WHEN CALLED BACK. THE MOTHER REPORTED THE FOLLOWING BLOOD GLUCOSE HISTORY, CARBOHYDRATE INTAKE AND INSULIN TREATMENT FOR HER DAUGHTER LEADING UP TO HER HOSPITAL VISIT. DATE (B)(6): TIME 7:32 AM, BG (MG/DL) 337, CHO (G) 66, BOLUS (U) 13.5; TIME 12:00 PM, BG (MG/DL) 216, CHO (G) 89, BOLUS (U) 10.75 (MOTHER REPORTED THAT HER DAUGHTER WAS FEELING HIGH AROUND THIS TIME, BUT DID NOT WANT TO CHECK HER BG); TIME 9:01 PM, BG (MG/DL) HIGH (>500 MG/DL); TIME 10:31 PM, BG (MG/DL) HIGH (>500 MG/DL). DATE (B)(6): TIME 12:18 AM, BG (MG/DL) 437 ( MOTHER REPORTED NO DINNER BOLUS WAS DELIVERED THE EVENT OF 4/29); TIME 5:38 AM, BG (MG/DL) 282 (NO BREAKFAST); TIME 8:16 AM, BG (MG/DL) 308; TIME 9:43 AM, BG (MG/DL) 281. THE CALLER REPORTED THAT THEY WENT TO THE HOSPITAL AT ABOUT THIS TIME. AT 8:01 PM ON (B)(6) HER DAUGHTER'S BG WAS 347 MG/DL. THE PATIENT IS NOT IN DIABETIC KETOACIDOSIS, BUT REMAINS IN THE HOSPITAL TO BE MONITORED AND TO ENSURE THAT SHE STABILIZES. THE POD WAS REMOVED AND DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238563 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LFR INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization