BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 9119612 · Received September 25, 2019

    Report

    Report Number
    3004464228-2019-09256
    Event Type
    Injury
    Date Received
    September 25, 2019
    Date of Event
    September 9, 2019
    Report Date
    September 9, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K162296
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS DID NOT OBSERVE ANY ISSUES THAT WOULD RESULT IN A FAILURE TO DELIVER INSULIN.CORRECTION TO D(4): LOT NUMBER CHANGED FROM UNAVAILABLE TO L43509. EXPIRATION DATE CHANGED FROM UNAVAILABLE TO 11/14/2020. MODEL NO CHANGED FROM 14000 TO 19191. SEQUENCE NUMBER CHANGED FROM UNAVAILABLE TO 0630214. CORRECTION TO G(5) - PMA/510(K) # CHANGED FROM K122953 TO K162296. UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4) TO(B)(4). CORRECTION TO H(4): DEVICE MFG DATE CHANGED FROM UNAVAILABLE TO 5/14/2019.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND DIABETIC KETOACIDOSIS. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE. MODEL: UST400. 17845-5A-AW REV B 09/17. CHECKING YOUR BLOOD GLUCOSE. CHAPTER 4 / PAGE 36. WARNINGS: TEST RESULTS BELOW 70 MG/DL MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA). TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS BELOW 70 MG/DL OR ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA (SEE "LIVING WITH DIABETES" ON PAGE 115), REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 70 MG/DL OR ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER. CHECKING YOUR BLOOD GLUCOSE. CHAPTER 4 / PAGE 42. WARNING: BLOOD GLUCOSE READINGS THAT ARE ESPECIALLY LOW OR HIGH CAN INDICATE POTENTIALLY SERIOUS CONDITION REQUIRING IMMEDIATE MEDICAL ATTENTION. IF LEFT UNTREATED, THIS SITUATION CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA), SHOCK, COMA, OR DEATH. LIVING WITH DIABETES. CHAPTER 11 / PAGE 119. AVOID LOWS, HIGHS, AND DKA. YOU CAN AVOID MOST RISKS RELATED TO USING THE OMNIPOD® SYSTEM BY PRACTICING PROPER TECHNIQUES AND BY ACTING PROMPTLY AT THE FIRST SIGN OF HYPOGLYCEMIA, HYPERGLYCEMIA, OR DIABETIC KETOACIDOSIS. THE EASIEST AND MOST RELIABLE WAY TO AVOID THESE CONDITIONS IS TO CHECK YOUR BLOOD GLUCOSE OFTEN. LIVING WITH DIABETES. CHAPTER 11 / PAGE 126. WARNINGS: IF LEFT UNTREATED, DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, AND EVENTUALLY DEATH. IF YOU NEED EMERGENCY ATTENTION, ASK A FRIEND OR FAMILY MEMBER TO TAKE YOU TO THE EMERGENCY ROOM OR CALL AN AMBULANCE. DO NOT DRIVE YOURSELF. TO AVOID DKA. THE EASIEST AND MOST RELIABLE WAY TO AVOID DKA IS BY CHECKING YOUR BLOOD GLUCOSE AT LEAST 4¿6 TIMES A DAY. ROUTINE CHECKS ALLOW YOU TO IDENTIFY AND TREAT HIGH BLOOD GLUCOSE BEFORE DKA DEVELOPS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT NIGHT, THE PATIENTS MOTHER NOTICED HE WAS GOING A LITTLE HIGHER THAN USUAL WITH HIS BLOOD GLUCOSE. SHE GAVE HIM A BOLUS TO LOWER THE BLOOD GLUCOSE AND THEY WENT DOWN A LITTLE BIT. ON SUNDAY (B)(6) 2019 THE PATIENTS MOTHER STATED THAT HE STARTED TO VOMIT AND FEEL WORSE. WHEN THE MOTHER CHECKED HIS BLOOD GLUCOSE IT SHOWED HIGH, MEANING OVER 500 MG/DL. THROUGHOUT THE NIGHT HIS BLOOD GLUCOSE WAS BETWEEN 350 MG/DL AND 400 MG/DL. IN THE MORNING OF (B)(6) 2019 HE WAS FEELING WORSE AND HIS BLOOD GLUCOSE WAS 386 MG/DL. THE POD WAS WORN FOR MORE THAN 48 HOURS ON THE ABDOMEN. THE MOTHER TOOK THE PATIENT TO THE EMERGENCY ROOM (ER). WHILE AT THE ER, THEY ADVISED HE WAS NOT GETTING ANY INSULIN. THEY CHECKED KETONES AND THEY WERE LARGE. THE HOSPITAL DIAGNOSED THE PATIENT WITH DIABETIC KETOACIDOSIS (DKA). THE HOSPITAL ADVISED TO DEACTIVATE THE POD. THEY TREATED THE PATIENT WITH 3 DIFFERENT IVS. ONE WAS AN INSULIN DRIP, ONE OF SALINE, AND THE LAST ONE WAS GLUCOSE. THEY ALSO GAVE HIM PEPCID MEDICATION TO HELP WITH HIS NAUSEA. HE WAS PLACED IN THE INTENSIVE CARE UNIT (ICU) AND WAS RELEASED ON 12 SEP 2019 WHEN HIS FLUIDS AND BLOOD GLUCOSE WERE UNDER CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910836 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44823 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization