BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH, PODS 10-PACK

    MDR report key: 21919187 · Received April 28, 2025

    Report

    Report Number
    3004464228-2025-18184
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    October 27, 2024
    Report Date
    April 28, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000112
    PMA / PMN Number
    K211575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT APPLIED A NEW POD ON (B)(6) 2024 BETWEEN 9:30AM AND 10AM. BY THE AFTERNOON, THE PATIENT'S BLOOD GLUCOSE LEVELS WERE STARTING TO INCREASE. THE PATIENT WAS TRAVELLING FOR WORK AND DID NOT HAVE A BACK UP METHOD OF DELIVERING INSULIN. THE PATIENT ARRIVED HOME BETWEEN 23:30 TO 00:00 AND TRIED APPLY MORE INSULIN BEFORE GOING TO BED. THE PATIENT WOKE UP AT 1:30AM AND HER BLOOD GLUCOSE LEVELS WERE SO ELEVATED THEY JUST READ HIGH (27.8 MMOL/L, 500 MG/DL). THE PATIENT'S SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA, FEELING THIRSTY, FREQUENT URINATION, FATIGUE, IMPAIRED SPEECH AND SWOLLEN HANDS. THE PATIENT CALLED THEIR DAUGHTER TO HELP, WHO CALLED AN AMBULANCE. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AT 2AM ON (B)(6) 2024 AND RELEASED THE NEXT DAY ON (B)(6) 2024. AT THE HOSPITAL THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND TREATED WITH INTRAVENOUS INSULIN AND WAS DIRECTED TO REMOVE THE POD AND ALWAYS HAVE A BACK UP METHOD ON THEM. THE POD WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581005 OMNIPOD DASH, PODS 10-PACK PUMP, INFUSION, INSULIN LZG INSULET CORPORATION PT-000029 20385082000112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization