BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 18703823 · Received February 14, 2024

    Report

    Report Number
    3004464228-2024-05390
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    January 10, 2024
    Report Date
    March 1, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS EVALUATED AND IN THE CASE DESCRIPTION, THE USER MENTIONED RECEIVING A SYSTEM ERROR ALARM. INSPECTION OF THE ANDROID LOG FILES DOWNLOADED FROM THE RETURNED CONTROLLER CONFIRMED THE GENERATION OF A SYSTEM ERROR ALARM OF ERROR CODE 50-50013-03651-006 ON THE DATE OF OCCURRENCE. INSPECTION OF THE LOGS FOUND THIS ERROR TO BE CAUSED BY A CROSSCHECK VERIFICATION FAILURE BETWEEN THE CONTROLLER AND THE PAIRED POD. DURING THE INVESTIGATION, THE CONTROLLER AND THE AGC ALGORITHM WERE FOUND TO FUNCTION AS INTENDED WITH NO EVIDENCE OF AN OVERDELIVERY OF INSULIN OR POD COMMUNICATION ERRORS AFTER THE SYSTEM ERROR BEING OBSERVED. THE EXACT CAUSE OF THE CROSSCHECK VERIFICATION AND SUBSEQUENT SYSTEM ERROR ALARM COULD NOT BE DETERMINED. THE CONTROLLER WAS RECEIVED WITH DAMAGE TO THE BOTTOM LEFT CORNER OF THE LCD. THIS DAMAGE DID NOT IMPACT LCD READABILITY OR TOUCH FUNCTIONALITY. THE EXACT CAUSE AND TIMING OF THE DAMAGE COULD NOT BE DETERMINED.

    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 HOSPITALIZATION AND HYPOGLYCEMIA. 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 · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPOGLYCEMIA. THE PATIENT REPORTS HAVING A APPLICATION ERROR ON THEIR CONTROLLER THAT THEY WERE UNABLE TO CLEAR TO START A NEW POD. AS TREATMENT THE PATIENT ADMINISTERED MANUAL INSULIN. ONCE AT THE HOSPITAL THE PATIENTS POD WAS REMOVED AND THE PATIENT RECEIVED TREATMENT. THE PATIENT REMAINS IN THE HOSPITAL AT THE TIME OF THIS CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388814 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 H000512

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Hospitalization