BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 11652424 · Received April 12, 2021

    Report

    Report Number
    3004464228-2021-05366
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    March 6, 2021
    Report Date
    March 31, 2021
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    10385082000009
    PMA / PMN Number
    K192659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PDM ERRORS WERE SEEN IN THE DATA ON THE OCCURRENCE DATE OR THE DAY THE PDM WAS LAST USED. A NEW POD WAS PAIRED WITH THE PDM. BOLUS DELIVERY WAS TESTED AND A 5U BOLUS WAS DELIVERED. NO ISSUES WERE NOTED DURING INSULIN DELIVERY. NO ISSUES SEEN WITH POD DATA. POD SUCCESSFULLY COMMUNICATED WITH PDM AT 5¿ DISTANCE, ADMINISTERING 1U BOLUS. IT WAS NOTED THAT ENTRIES IN THE .IBF FILE REGARDING BASAL RATE WERE RECORDED OUT OF CHRONOLOGIC ORDER (FIG 1). THE DEVICE UI DID NOT REFLECT THIS DISCREPANCY, DISPLAYING CORRECT INFORMATION. THIS WOULD NOT AFFECT INSULIN DELIVERY. REMOVE D4 - UNIQUE IDENTIFIER (UDI) # (B)(4). REMOVE D4 - LOT NO = L000275. ADD D4 - UNIQUE IDENTIFIER (UDI) # (B)(4). ADD D4 - LOT NO = L000277.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE VALUES REACHED OVER 1000 MG/DL. THE PATIENT LOST CONSCIOUSNESS, AS A RESULT. FOR TREATMENT, THE PATIENT WAS GIVEN A INSULIN DRIP AND PUT IN THE INTENSIVE CARE UNIT (ICU). THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON A UNKNOWN LOCATION. THE PATIENT WAS DISCHARGED AFTER 1 WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548843 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18239 L000277 10385082000009

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R