BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 APP

    MDR report key: 17986674 · Received October 23, 2023

    Report

    Report Number
    3004464228-2023-29645
    Event Type
    Injury
    Date Received
    October 23, 2023
    Date of Event
    October 2, 2023
    Report Date
    October 2, 2023
    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 REPORTED EVENT OCCURRED DUE TO A SOFTWARE DEFECT THAT IS SUBJECT TO A FIELD SAFETY CORRECTION. REFERENCE FDA:RES NUMBER (B)(4). D1 - BRAND NAME CHANGED TO OMNIPOD 5 APP D4 - UNIQUE IDENTIFIER (UDI) # (B)(4). D4 - SERIAL # (B)(6). D4 - MODEL # PT-000409. D4 - CATALOG #PDM-H001-G-XX.

    Additional Manufacturer Narrative · 0

    THE CASE DESCRIPTION STATES THAT THE USER GAVE A 9 UNIT BOLUS INSTEAD OF A 0.9 UNIT BOLUS LEADING TO HYPOGLYCEMIA. THE PHYSICAL CONTROLLER WAS NOT RECEIVED FOR INVESTIGATION. ANDROID LOG FILES FROM THE COMPLAINT DEVICE WERE UPLOADED TO THE CLOUD SYSTEM BY THE USER AND DOWNLOADED FOR INVESTIGATION. INSPECTION OF THE ANDROID LOG FILES FOUND NO 9U OR 0.9U BOLUSES DELIVERED ON THE DATE OF OCCURRENCE. THE LOGS SHOW THAT THE LAST BOLUS DELIVERED ON THE DATE OF OCCURRENCE WAS AN 8U BOLUS DELIVERED AT 16:07 IN THE USERS TIME. THE LOGS SHOW THAT THE CONTROLLER WAS INTERACTED WITH TO ENTER THE BOLUS CALCULATOR SCREEN, HAD NO CARB VALUES ENTERED, AND THE USE CGM OPTION WAS USED TO LOAD A BG VALUE OF 184 MG/DL. THE LOGS SHOW THAT THE SUGGESTION BASED ON THE SMARTBOLUS CALCULATOR WAS 0.5U, AND THEN THE USER ATTEMPTED TO ADJUST THE TOTAL BOLUS PAST THE MAX BOLUS. THE USER ADJUSTED BOLUS VOLUME WAS FOUND TO BE 7.5U IN ADDITION TO THE 0.5 U TOTALING TO THE 8U BOLUS GIVEN. FINALLY, THE CONTROLLER WENT THROUGH THE STEPS TO CONFIRM AND START THE BOLUS. NO PROBLEM WAS FOUND WITH THE SYSTEM.

    Additional Manufacturer Narrative · 0

    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 HYPOGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SOUGHT MEDICAL INTERVENTION DUE TO USER ERROR. THE PATIENT REPORTED THEIR OP5 SMARTPHONE APP DID NOT ACKNOWLEDGE THE DECIMAL POINT WHEN GIVING HIMSELF A BOLUS SO HE MISTAKENLY GAVE HIMSELF 9 UNITS OF INSULIN INSTEAD OF 0.9 UNITS. CALLER SAID HE WAS GIVEN GLUCOSE AND HE WAS KEPT UNDER SUPERVISION. THE PATIENT WENT TO THE HOSPITAL WITH 4 GATORADES TO DRINK AND HALF A POUND SUGAR AND WAS DIRECTED TO CONSUME THEM. THE PATIENT WAS ADMITTED FOR THREE HOURS AND WAS RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980392 OMNIPOD 5 APP ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Hospitalization