BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 15502187 · Received September 29, 2022

    Report

    Report Number
    3004464228-2022-17987
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    September 22, 2022
    Report Date
    September 23, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    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

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED EMERGENCY ROOM VISIT AND HYPERGLYCEMIA. 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.

    Additional Manufacturer Narrative · 0

    AN 0X1C ALARM WAS GENERATED, INDICATING THE POD REACHED THE EXPIRATION TIME. THE DOWNLOADED DATA CONFIRMS THE DEVICE RAN FOR 80 HOURS. THE DEVICE FUNCTIONED AS INTENDED. THE DOWNLOADED DATA DOES NOT SHOW ANY TIMEOUTS OR DRIVE STALLS DURING THE RUN THAT WOULD INDICATE A FAILURE TO DELIVER INSULIN. CORRECTION TO (D1): BRAND NAME FROM UNAVAILABLE TO OMNIPOD INSULIN PUMP. CORRECTION TO (D2A): COMMON DEVICE NAME FROM UNAVAILABLE TO PUMP, INFUSION, INSULIN CORRECTION TO D(4): CATALOG NO CHANGED FROM UNAVAILABLE TO ZXR425. CORRECTION TO G(4): PMA/510(K)# FROM UNAVAILABLE TO K192659.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE (BG) READ "HIGH" (>27.8 MMOL/L,>500 MG/DL) WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. THE PATIENT WAS TREATED WITH A MANUAL INSULIN INJECTION OF 4 UNITS AND THE DOCTOR APPLIED A NEW POD TO CONTINUE INSULIN TREATMENT UTILIZING THE OMNIPOD SYSTEM. THE PATIENT WAS RELEASED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926016 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN QFG INSULET CORPORATION 15880 L46187

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female Required Intervention