BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 15506835 · Received September 29, 2022

    Report

    Report Number
    3004464228-2022-18050
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    September 18, 2022
    Report Date
    September 19, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K192659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND DIABETIC KETOACIDOSIS. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. HIGH BLOOD GLUCOSE IS A COMMON SYMPTOM FOR PEOPLE WITH DIABETES (GLUCOSE MONITORING DATA FROM PEOPLE WITH DIABETES INDICATE THAT ON AVERAGE, THEY CAN EXPERIENCE BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL FOR 14-25% OF THE TIME[1][2][3]..), AND IT WOULD BE CHALLENGING TO SPECULATE ON A CAUSE FOR THE COMPLAINTS WITHOUT RECEIVING THE DEVICES BACK FOR AN ENGINEERING INVESTIGATION. [1] BECK RW, BERGENSTAL RM, CHENG P, KOLLMAN C, CARLSON AL, JOHNSON ML, RODBARD D. THE RELATIONSHIPS BETWEEN TIME IN RANGE, HYPERGLYCEMIA METRICS, AND HBA1C. J DIABETES SCI TECHNOL 2019;13:614-626 [1] WELSH JB, DERDZINSKI M, PARKER AS, PUHR S, JIMENEZ A, WALKER T. REAL-TIME SHARING AND FOLLOWING OF CONTINUOUS GLUCOSE MONITORING DATA IN YOUTH. DIABETES THER 2019;10:751-755 [1] PUHR S, DERDZINSKI M, WELSH JB, PARKER AS, WALKER T, PRICE DA. REAL-WORLD HYPOGLYCEMIA AVOIDANCE WITH A CONTINUOUS GLUCOSE MONITORING SYSTEM'S PREDICTIVE LOW GLUCOSE ALERT. DIABETES TECHNOL THER 2019;21:155-158.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D1 - BRAND NAME CHANGED FROM UNAVAILABLE TO OMNIPOD INSULIN PUMP. D2A - COMMON DEVICE NAME CHANGED FROM UNAVAILABLE TO PUMP, INFUSION, INSULIN. D2B - PROCODE CHANGED FROM UNAVAILABLE TO LZG. CORRECTION TO D(4): SEQUENCE NUMBER CHANGED FROM UNAVAILABLE TO 130410278. MODEL NO CHANGED FROM 18900-5A TO 14500-5A. CATALOG NO CHANGED FROM UNAVAILABLE TO UST400. UNIQUE IDENTIFIER (UDI) # CHANGED TO (B)(4). CORRECTION TO G(5): PMA/510(K) # CHANGED FROM UNAVAILABLE TO K192659.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD TO GO TO THE EMERGENCY ROOM (ER) DUE TO CONTROLLER NOT WORKING. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 587 MG/DL. SYMPTOMS REPORTED INCLUDE ABDOMINAL PAIN, NAUSEA AND CRAMPING. THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND WAS TREATED WITH AN INTRAVENOUS FLUIDS. THE PATIENT HAD NOT BEEN DISCHARGED AT THE TIME OF THE CALL. THE PATIENT'S BLOOD GLUCOSE AND INSULIN HISTORY ARE AS FOLLOWS: DATE BG(MG/DL) (B)(6) 2022 157 (B)(6) 2022 240 (B)(6) 2022 587.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121283 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14500-5A L60825
    1825294 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14500-5A L60825

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Hospitalization