BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 17398024 · Received July 26, 2023

    Report

    Report Number
    1226572-2023-00082
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    July 5, 2023
    Report Date
    July 6, 2023
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: AN ADDITIONAL FOUR DEVICES WERE RETURNED AND EVALUATED FOR THE REPORT OF HYPOGLYCEMIA WITH NO KNOWN DEVICE ISSUE. DEVICE #052992-A, B, AND C WERE INSPECTED AND THE NEEDLE MECHANISM FUNCTIONS WERE TESTED AND VERIFIED TO HAVE OPERATED AS INTENDED. THE COMPLAINT COULD NOT BE CONFIRMED FOR THESE DEVICES. DEVICE #052992-D WAS INSPECTED AND THE REPORTED COMPLAINT COULD NOT BE VERIFIED DUE TO THE RETURNED CONDITION OF THE DEVICE. THE COMPLAINT ABOUT THIS DEVICE COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    ADVERSE EVENT (AE) ASSESSMENT: AE ASSESSOR CONTACTED THE TYPE 2 DM, V-GO 30, HUMALOG INSULIN CLIENT. SHE STARTED ON THE V-GO DEVICE 1 WEEK AGO. CLIENT IS REPORTING SINCE USING THE V-GO DEVICE SHE HAS HAD BLOOD SUGARS 40 ML/DL. SHE TREATED THE LOW BLOOD SUGAR READINGS WITH JUICE AND FOOD WITH GOOD RESPONSE. SHE CONTACTED HER HCP REGARDING THE LOW BLOOD SUGARS READINGS AND WAS ADVISED ON HOW TO ADJUST INSULIN, BOLUS CLICKS. SHE RESPONDED WELL WITH THE INSULIN ADJUSTMENT AND NO ADDITIONAL MEDICAL TREATMENT WAS NEEDED. NO CHANGES IN DAILY ROUTINE OF DIET, PHYSICAL ACTIVITY, ACUTE ILLNESS, STRESS OR MEDICAL TREATMENT IS REPORTED WITH THE BLOOD SUGAR READINGS. CLIENT REPORTS NO ISSUES WITH THE NEEDLE START BUTTON, BOLUS READY OR DELIVERY BUTTON. THE LOW BLOOD SUGAR READING MAY BE RELATED TO NEW INSULIN ADMINISTRATION. A BLOOD SUGAR READING OF 40 CAN BE CONSIDERED SERIOUS, WITH POSSIBILITY OF RECURRENCE. IT IS POSSIBLE THE V-GO DEVICE CONTRIBUTED. DEVICE EVALUATION: EIGHT DEVICES WERE RETURNED AND EVALUATED FOR THE REPORT OF HYPOGLYCEMIA. ALL DEVICES WERE VISUALLY INSPECTED WITH NO ISSUES FOUND. FUNCTION TESTS WERE PERFORMED, AND ALL DEVICES PASSED TESTING. NONE OF THE DEVICES RETURNED APPEAR TO HAVE MALFUNCTIONED IN A WAY THAT WOULD CONTRIBUTE TO A HYPOGLYCEMIA EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOOD SUGAR LEVELS OF 40 ML/DL. NO MEDICAL INTERVENTION WAS REQUIRED. THE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661269 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other