BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 11568137 · Received March 25, 2021

    Report

    Report Number
    1226572-2021-00115
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    March 1, 2021
    Report Date
    March 10, 2021
    Manufacturer
    ZEALAND PHARMA U.S. INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE ZEALAND PHARMA AE ASSESSOR SPOKE WITH THE VGO USER FOR FURTHER INVESTIGATION OF THE COMPLAINTS OF NEEDLE BUTTON DID NOT LOCK DOWN IN 2-3 DEVICES, NEEDLE RELEASE BUTTON DID NOT RETRACT THE NEEDLE, HYPERGLYCEMIA UP TO 500PLUS MG/DL OCCURRING 4 WEEKS TO SEVERAL WEEKS AGO, HYPOGLYCEMIA AND OTHER MEDICATION FOR ANXIETY. THE VGO USER REPORTED THE NEEDLE BUTTON DID NOT LOCK DOWN IN 2-3 DEVICES ABOUT 4 WEEKS AGO. SHE WAS NOT ABLE TO RECALL INFORMATION RELATED TO THE EVENTS EXCEPT THAT SHE WAS AWAY FROM HOME FOR ONE EVENT SO COULD NOT REPLACE THE VGO. SHE TRIED TO SECURE THE VGO WITH TAPE (WHICH LIKELY MEANT THE VGO AND VGO NEEDLE WERE DETACHED FROM THE VGO SITE) AND HER BG LEVEL DID INCREASE BUT SHE DID NOT RECALL TO WHAT LEVEL. WHEN THE NEEDLE RELEASE BUTTON DID NOT WORK ABOUT A MONTH AGO SHE WAS ABLE TO REMOVE THE VGO WITHOUT A PROBLEM BUT COULD NOT REMEMBER ANY OTHER INFORMATION RELATED TO THE EVENT. SHE DID REPORT HER SKIN IS CLEAR TODAY (B)(6) 2021 WITH NO SCRATCHES. SHE WEARS THE VGO ON HER ABDOMEN AND CHANGES IT EVERY 24 HOURS. SHE HAS NOT BEEN MONITORING THE INSULIN VIEWING WINDOW; AE ASSESSOR ENCOURAGED HER TO AND WHY IT WAS IMPORTANT TO DO SO. HER PRE-VGO BG RANGE 250-299 MG/DL, A1C 8 SOMETHING, USING SLIDING SCALE INSULIN. USING VGO 30 BG 69-500 PLUS MG/DL, A1C 10.3%, AND WAS USING OFF LABEL REGULAR INSULIN IN VGO. REGULAR INSULIN IS OFF LABEL USE FOR VGO BUT A HCP MAY PRESCRIBE FOR OFF LABEL USE. SHE WAS TAKING 2-3 CLICKS AT BEDTIME BUT DISCONTINUED THIS PRACTICE BECAUSE OF ANXIETY. SHE IS TAKING 4 CLICKS WITH BLOOD GLUCOSE LEVEL LESS THAN 150 AT MEALS, 5 CLICKS WHEN BG GREATER THAN 150 MG/DL, AND 6 CLICKS WHEN BG GREATER THAN 200MG/DL. VGO USER?S HCP PRESCRIBED HUMALOG U 100 FOR VGO SEVERAL DAYS AGO AND BG LAST NIGHT 3/16/21 WAS 157 MG/DL AND THIS MORNING (B)(6) 2021 150 MG/DL. SHE MENTIONS SHE HAS DIFFERENCES IN EATING FROM TIME TO TIME DUE TO DATE NIGHTS WITH HER SPOUSE AND EVENTS SUCH AS FUNERALS WHICH EFFECTS BG LEVEL. SHE ALSO HAS HAD INCREASED ANXIETY DUE TO A CLOSE FAMILY MEMBER SUFFERING FROM AN ILLNESS THAT CAUSED HIS PASSING. AS WELL AS A MEDICAL HISTORY OF ANXIETY, IBS, AND FIBROMYALGIA WITH KNEE AND LEG PAIN ALL OF WHICH MAY INCREASE BG. WHEN BG INCREASED TO THE 500 PLUS LEVEL VGO USER HAS HEADACHES AND DID NOT FEEL WELL. THE VGO USER COULD NOT PROVIDE THE DATES AND TIMES OF THE BG INCREASED TO 500 PLUS NOR RECALL ANY SPECIFIC INFORMATION RELATED TO THEM. THERE IS LIKELY A LOGICAL REASON FOR THE HYPERGLYCEMIA WHICH INCLUDES THE INCREASED ANXIETY DUE TO LIFE EVENTS, DIFFERENCES IN EATING, PAIN FROM HER MEDICAL PROBLEMS, AND USE OF NOVOLIN REGULAR INSULIN. SHE HAS NOT STARTED USING THE VGO 40 YET. SHE WEARS A CONTINUOUS GLUCOSE MONITOR WHICH THE DR. UPLOADS AND REVIEWS. WHEN THE VGO USER HAD THE BG OF 69 MG/DL SIX WEEKS AGO, SHE FELT LIGHT-HEADED AND WAS SWEATY. SHE WAS ABLE TO MANAGE IT WITH ORAL CARBOHYDRATES WITH A PROMPT RESPONSE BUT COULD NOT SAY WHAT HER BLOOD GLUCOSE LEVEL INCREASED TO. THERE WAS A LOGICAL REASON FOR THE HYPOGLYCEMIA THE VGO USER HAS DIFFERENCES IN EATING WHICH LIKELY CONTRIBUTED. SINCE HER HCP SWITCHED THE NOVOLIN REGULAR TO HUMALOG U100 AND THE VGO USER LEVEL OF STRESS HAS IMPROVED SHE HAS EXPERIENCED BG IN THE MID-100S.

    Description of Event or Problem · 1

    THE PATIENT REPORTED EXPERIENCED HYPERGLYCEMIA SEVERAL TIMES, SOME WEEKS AGO. THE PATIENT REMEMBERED THAT HER HIGHEST READINGS WERE APPROXIMATELY 500 OR ABOVE. THE PATIENT DID NOT PROVIDE EXACT DATES AND VALUES. THE PATIENT ONLY MENTIONED THAT THIS HAPPENED MAY A MONTH AGO DURING THE WHOLE DAY. THE PATIENT INDICATED THAT SHE HAS HIGH READINGS VERY OFTEN NOW AND SINCE BEING DIABETIC FOR ABOUT 27 YEARS. THE PATIENT INDICATED THAT HER NORMAL READINGS ARE AROUND 180.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464861 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG ZEALAND PHARMA U.S. INC. V-GO 30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening