BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-GO DISPOSABLE INSULIN DELILVERY DEVICE

    MDR report key: 10013617 · Received April 30, 2020

    Report

    Report Number
    1226572-2020-00130
    Event Type
    Injury
    Date Received
    April 30, 2020
    Date of Event
    March 23, 2020
    Report Date
    April 10, 2020
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO REPORTED CASES OF DKA WERE CAPTURED ON COMPLAINT (B)(4) AWARE DATE OF 12/16/19. THE AE ASSESSOR SPOKE WITH THE PATIENT FOR FURTHER INVESTIGATION OF THE REPORT OF TWO HOSPITALIZATIONS FOR DKA. THE PATIENT REPORTED THAT SHE FREQUENTLY REMOVES THE VGO FOR HOURS TO A FEW DAYS. THE PATIENT STATED THAT WHEN SHE WAS HOSPITALIZED FOR DKA WITH THE SYMPTOMS OF HYPERGLYCEMIA (VOMITING, NAUSEA AND FATIGUE), SHE HAD NOT BEEN WEARING THE VGO DEVICE FOR "HOURS TO DAYS." THE PATIENT COULD NOT REMEMBER IF SHE HAD ONLY GONE WITHOUT INSULIN A FEW HOURS OR OVERNIGHT OR WITHOUT INSULIN LONGER THAN ONE DAY. THE PATIENT REPORTED SHE WAS ONLY TAKING JARDIANCE FOR BG MGMT., NOT USING THE VGO, WHEN SHE HAD BOTH EPISODES OF REPORTED DKA. WHEN THE PATIENT HAD THE BG OF 600 ON (B)(6) 2019 SHE HAD GONE WITHOUT WEARING A VGO FOR HOURS PRIOR TO THE BG VALUE OF 600. THE PATIENT ONLY RECEIVES INSULIN WHEN SHE WEARS THE VGO; SHE DOES NOT TAKE INSULIN BY INJECTION. THE PATIENT STATED HER ENDOCRINOLOGIST LEFT THE PRACTICE BEFORE THE EPISODES OF DKA AND SHE HAS NOT FOLLOWED UP WITH ANOTHER ENDOCRINOLOGIST. THE PATIENT STATED THE HOSPITAL HCP TOLD HER THE DKA WAS RELATED TO JARDIANCE BEING USED TO MANAGE HER BG AND HE INSTRUCTED HER TO STOP THE JARDIANCE. THE PATIENT DOES NOT HAVE A BACK-UP PLAN TO MANAGE HER DIABETES IF SHE DECIDES TO NOT APPLY A VGO. IF THE PT. REQUIRES INSULIN FOR BG MGMT., GOING WITHOUT INSULIN WOULD CAUSE HYPERGLYCEMIA WITH POSSIBLE DKA. THE PT. WAS VERY CLEAR TO THE AE ASSESSOR THAT SHE HAD NOT WORN HER VGO DEVICE AND HAD GONE WITHOUT INSULIN FOR HOURS TO DAYS PRIOR TO THE DKA AND ALSO WHEN SHE HAD THE BG OF 600 ON (B)(6) 2019. THE DKA EPISODES AND BG OF 600 ARE UNRELATED TO DEVICE MALFUNCTION AS THE PATIENT HAD NOT WORN THE VGO AND WENT WITHOUT INSULIN. THE PATIENT HAS NOT RETURNED THE AE ASSESSOR CALLS TO ALLOW FOR FURTHER INVESTIGATION OF THE REPORT OF HOSPITALIZATION FOR DIABETIC KETOACIDOSIS (DKA) IN (B)(6) 2020). THE PATIENT DID SHARE WITH VALERITAS THAT RECENTLY SHE HAD WORN ONE VGO FOR 2 DAYS IN (B)(6) 2020. A SINGLE VGO DEVICE IS NOT APPROVED FOR USE FOR MORE THAN 24 HOURS. WEARING ONE VGO FOR MORE THAN 24 HOURS COULD CAUSE HYPERGLYCEMIA. IT SHOULD NOTED THAT THE PATIENT HAS INFORMED VALERITAS SHE HAS RECENTLY WORE ONE VGO FOR 2 DAYS. THE PATIENT BEHAVIOR COULD BE A CONTRIBUTORY FACTOR TO HYPERGLYCEMIA.

    Description of Event or Problem · 1

    THE PATIENT WENT TO THE HOSPITAL FOR DKA FROM (B)(6) 2019, THEN WENT AGAIN FROM (B)(6) 2019, AND AGAIN FROM (B)(6) 2020 FOR DIABETIC KETOACIDOSIS ALL THREE TIMES. PATIENT SAID SHE THREW UP EACH TIME. PATIENT THREW AWAY THE V-GO SHE WORE UPON ENTERING THE HOSPITAL EACH TIME. THE PATIENT SAID SHE WORE HER LAST V-GO BEYOND 24 HOURS AND THAT WAS ABOUT TWO DAYS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478776 V-GO DISPOSABLE INSULIN DELILVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 20 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization