BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 14803168 · Received June 24, 2022

    Report

    Report Number
    1226572-2022-00082
    Event Type
    Injury
    Date Received
    June 24, 2022
    Date of Event
    June 1, 2022
    Report Date
    June 2, 2022
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    UDI-DI
    00385609400025
    PMA / PMN Number
    K103825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANNKING AE ASSESSOR SPOKE TO THE PATIENT REGARDING HIGH BLOOD GLUCOSE READING ON 6/1 ABOVE 500. BLOOD GLUCOSE READING OVER 400 IS CONSIDERED SERIOUS. ON THIS DAY THE PATIENT HAD A V-GO DEVICE THAT HAD FALLEN OFF. PATIENT DID NOT HAVE A NEW V-GO DEVICE TO PUT ON, WAS WAITING FOR NEW DEVICES TO BE DELIVERED. PATIENT WAS TREATING HIS BLOOD SUGARS WITH HUMALOG AND DID NOT HAVE A LONG ACTING INSULIN AT HOME. DELAY IN RECEIVING INSULIN FROM THE DEVICE FALLING OFF AND NOT IMMEDIATELY REPLACING THE V-GO DEVICE CONTRIBUTED TO THE ELEVATED BG READING OF 500. PATIENT REPORTS MANAGING BLOOD SUGARS WITH HUMALOG INSULIN INJECTIONS WHEN DEVICE FELL OFF AND DID NOT HAVE A LONG ACTING INSULIN AVAILABLE. PATIENT IS WORKING WITH HIS HCP TO HAVE INSULIN PLAN OF CARE FOR TREATMENT WHEN DEVICE FALLS OFF OR IF DEVICE IS NOT AVAILABLE. REFERRED PATIENT TO THE V-GO MANUAL PAGE 5 TO AMOUNT OF INSULIN V-GO 20 AND 30 PROVIDES. CLIENT WAS HOSPITALIZED IN MAY FOR HEART FAILURE. WIFE AND CLIENT REPORT THE V-GO DEVICE AND BLOOD SUGAR READINGS DID NOT CONTRIBUTE TO THIS ADMISSION. CLIENT IS CLOSELY MONITORING HIS BLOOD GLUCOSE READINGS AND WORKING WITH HIS HCP AND IMPLEMENTING CHANGES TO HIS MEDICAL PLAN. BLOOD GLUCOSE READING OF 40 AND 500 ARE CONSIDERED SERIOUS. DEVICE CONTRIBUTION CANNOT BE EXCLUDED. THIS MDR WAS CREATED BY (B)(6), DEVICE VIGILANCE SPECIALIST OF ZEALAND PHARMA US, INC. ON BEHALF OF THE MANNKIND, CORP. AS PART OF THE ACQUISITION AND SUBSEQUENT TRANSFER OF THE V-GO MEDICAL DEVICE TO THE LATTER ORGANIZATION. THIS TEMPORARY TRANSITION ACTIVITY IS EXPECTED TO CONTINUE UNTIL SUCH TIME THAT THE ACQUIRING COMPANY ESTABLISHES ITS OWN MDR REPORTING ACCOUNT.

    Description of Event or Problem · 0

    THE PATIENT'S WIFE REPORTED THAT PATIENT EXPERIENCED A HBG ON (B)(6) 2022 6:00 PM (ABOVE 500). PATIENT HAS A NORMAL BG RANGE OF 100-150 AND AT THE TIME OF THE CALL HIS BGL WAS 359. PATIENT AND WIFE WILL CONTACT HCP FOR FURTHER INSTRUCTION. PATIENT IS CURRENTLY PRESCRIBED THE V-GO 30 DEVICE AND WILL BE SWITCHING TO THE V-GO 20 WHEN THE ORDER IS DELIVERED. PATIENT WAS ABLE TO RECOGNIZE AND TREAT HIS HBG BY APPLYING A NEW V-GO DEVICE AND ADMINISTERING CLICKS. PATIENT EXPERIENCED SIMILAR EVENTS WHILE IN THE PAST WHILE USING V-GO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055774 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-GO 30 VG321059C 00385609400025

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Life Threatening