BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 14800656 · Received June 24, 2022

    Report

    Report Number
    1226572-2022-00075
    Event Type
    Injury
    Date Received
    June 24, 2022
    Date of Event
    May 26, 2022
    Report Date
    May 31, 2022
    Manufacturer
    MANNKIND CORPORATION - V-GO
    Product Code
    LZG
    UDI-DI
    00385609400032
    PMA / PMN Number
    K103825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANNKIND AE ASSESSOR SPOKE TO THE PATIENT FOR FURTHER INVESTIGATION OF THE COMPLAINTS OF HYPERGLYCEMIA GREATER THAN 500MG/DL, INSULIN RUNNING DOWN THE BACK OF HER ARM AND VGO LEFT KNOTS ON HER ABDOMEN. PATIENT WORE THE VGO ON HER ABDOMEN FOR SEVERAL MONTHS USING THE RIGHT SIDE THEN THE LEFT AND THE KNOTS WOULD BE PRESENT FOR 1-2 WEEKS. THEN SHE SWITCHED TO PLACING THE VGO ON THE BACK OF THE ARM. PATIENT EXPERIENCED BG GREATER THAN 500MG/DL RESOLVING TO 395 ON (B)(6) 2022 AND BG GREATER THAN 500 RESOLVING TO 200'S MG/DL ON (B)(6) 2022. EVEN THOUGH THE NEEDLE WAS IN HER TISSUE THE INSULIN RAN DOWN HER ARM. WHEN THE BG WAS ELEVATED SHE FELT LETHARGIC, BREATHING WAS IN A SENSE LABORED AND SHE SLEPT IT OFF. PATIENT DID INCREASE HER LIQUIDS BY CONSUMING TEA. HER USUAL BG IS 80-180 MG/DL, A1C IS 8% AND TAKES 0-1 CLICKS WITH MEALS. PATIENT WEARS THE VGO FOR 24 HOURS BUT HAS NOT BEEN MONITORING THE INSULIN VIEWING WINDOW. PATIENT WAS ENCOURAGED TO MONITOR THE INSULIN VIEWING WINDOW TO ENSURE THE INSULIN IS INFUSING. THIS IS A SERIOUS CASE DUE TO THE BG GREATER THAN 500 MG/DL AND THE PATIENT EXPERIENCING LETHARGY, BREATHING WAS IN A SENSE LABORED. THE VGO CANNOT BE EXCLUDED AS A CONTRIBUTOR TO THE AE. THE PATIENT IS IN CONTACT WITH HER HCP FOR BLOOD GLUCOSE AND MEDICAL MANAGEMENT. 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 REPORTED THAT INSULIN HAS BEEN RUNNING DOWN THE BACK OF PATIENT ARM WITH THE LAST 2 V-GO 20 DEVICES WHEN GIVING CLICKS AND PATIENT HAS BEEN EXPERIENCING HYPERGLYCEMIA. THE PATIENT STATED THAT SHE HAS THE V-GO 20 DEVICES APPLIED ON THE BACK OF HER ARM AND DOES NOT REMOVE THE BUTTON COVER UNTIL AFTER THE V-GO WAS APPLIED TO THE BACK OF HER ARM. THE PATIENT WAS ADVISED TO REMOVE THE BUTTON COVER ON A FLAT SURFACE BEFORE REMOVING THE ADHESIVE LINER AND APPLYING THE V-GO. THE PATIENT RESPONDED THAT SHE DOES NOT THINK THIS WILL HELP BUT SHE WILL TRY IT. THE PATIENT STATED THAT SHE FIRST NOTICED HYPERGLYCEMIA BETWEEN (B)(6) AND NOTICED THAT SHE WAS HAVING THE SAME ISSUE WHERE THERE WAS INSULIN ON HER HAND AND HER SUGAR WOULD NOT GO DOWN. THE PATIENT STATED THAT ON (B)(6) AT 12:30AM, HER BG WAS 82 WHICH WAS PRIOR TO APPLYING THE V-GO IN QUESTION. THE PATIENT STATED THAT ON (B)(6) AT 4:03PM, HER BG SHOWED AS HIGH (>500) SO SHE REMOVED THE V-GO AND SELF MANAGED TO BRING IT TO 395 AT 9:50PM. THE PATIENT STATED THAT ON (B)(6) AT 5:15PM, HER BG WAS HIGH AND HER LOWEST WAS 240 ON (B)(6) AT 11:22AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055659 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG MANNKIND CORPORATION - V-GO V-20 FG221111 00385609400032

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other