BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 18561804 · Received January 23, 2024

    Report

    Report Number
    3004464228-2024-02345
    Event Type
    Injury
    Date Received
    January 23, 2024
    Date of Event
    January 20, 2024
    Report Date
    March 24, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    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 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 MEDICAL INTERVENTION AND HYPOGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE POD WAS FOUND TO FUNCTION AS INTENDED WITH NO EVIDENCE OF ANY DAMAGES OR DEFICIENCIES THAT WOULD RESULT IN THE DEVICE OVER DELIVERING INSULIN. INSPECTION OF THE DOWNLOAD DATA SHOWED NO EVIDENCE OF ISSUES WITH INSULIN DELIVERY.

    Additional Manufacturer Narrative · 0

    THE PATIENT CALLED ON 24JANUARY2024 AND REPORTED A DIFFERENT LOT NUMBER THAN WAS REPORTED AND NOTED ON THE INITIAL MDR. CORRECTION TO D1- BRAND NAME FROM OMNIPOD DASH INSULIN MANAGEMENT SYSTEM TO OMNIPOD INSULIN PUMP; D4 MODEL NO CHANGED FROM 18320 TO 19191; D4 LOT # CHANGED FROM UNAVAILABLE TO L73149; D4 CATALOG NO CHANGED FROM BLE-I1-529 TO ZXP425; D4 SERIAL # CHANGED FROM UNAVAILABLE TO (B)(6); D4 EXPIRATION DATE CHANGED FROM UNAVAILABLE TO 4/5/2024; UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4) TO (B)(4); CORRECTION TO H(4): DEVICE MFG DATE CHANGED FROM UNAVAILABLE TO 10/5/2022; CORRECTION TO G(4): PMA/510(K)# FROM K211575 TO K192659.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ "LOW" (LESS THAN 3.9 MMOL/L (<70 MG/DL)) WHILE WEARING THE POD FOR BETWEEN 5 AND 24 HOURS. THE PATIENT WAS FEELING SHAKY AND CALLED EMERGENCY SERVICES. WHILE THE PATIENT WAS WAITING FOR THEM TO ARRIVE, THE PATIENT ATE AND DRANK AND THE BG LEVELS BEGAN INCREASING. THE PATIENT REMOVED AND DISCARDED THE POD FROM THE LEG. THE AMBULANCE ARRIVED AND TRANSPORTED THE PATIENT TO THE HOSPITAL. THE PATIENT KEPT EATING AND DRINKING AT THE HOSPITAL AND WAS MONITORED FOR APPROXIMATELY FIVE HOURS. NO ADDITIONAL TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1854068 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L73149 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male Required Intervention