MAUDE Adverse Event Report: MANNKIND CORPORATION - V-GO V-GO DISPOSABLE INSULIN DELIVERY DEVICE

Model Number V-GO 20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Hypoglycemia (1912); Discomfort (2330)

Event Date 02/24/2023

Event Type  Injury  

Event Description

The patient reported to the medical education team that they started medication on (b)(6) and patient stated that friday, saturday, and sunday night that she would wake up around 2am with sugars in 50/60.She was symptomatic all three nights and had to drink orange juice to treat herself.Patient was using a sample kit she received from the office.No device is available for return to the manufacturer for evaluation.

Manufacturer Narrative

Adverse event (ae) assessment: the ae assessor spoke briefly to this new v-go-20 user.She had been using the device since (b)(6) 2023.Prior to starting the v-go 20 she was taking 13 units of toujeo at bedtime.She states her bolus dose is determined by what she eats.She usually gives one click.She is a schoolteacher who likes the convenience of the v-go.She wears the continuous glucose monitor (cgm) libre.She states she has woken up at 2am for the past 3 nights.She gets sweaty, has a headache, and feels horrible.She treat the low glucose levels with orange juice, but then she over treats and her glucose goes up.Her hypoglycemia has been in the 50-60 range.She has not spoken to her healthcare practitioner (hcp).She states she doesn't eat after dinner.Ae assessor suggested a bedtime snack with protein and carb.Ae assessor told her to talk to her hcp for treatment guidance.She was on a lower dose of basal insulin prior to starting the v-go 20.Therefor the higher dose of 20 units of basal could be more than she needs.She does not wish to eat more food to chase the insulin.It is expected that there would be an adjustment to a new device.It is unlikely that the device is defective, but it contributed in that it contains more insulin than she requires.A glucose level of 50 could be considered serious, but the patient self-treated and corrected it on her own.

• Brand Name: V-GO DISPOSABLE INSULIN DELIVERY DEVICE
• Type of Device: V-GO
• Manufacturer (Section D): MANNKIND CORPORATION - V-GO; 293 boston post road w; #330; marlborough MA 01752
• Manufacturer (Section G): MANNKIND CORPORATION - V-GO; 293 boston post road w; #330; marlborough MA 01752
• Manufacturer Contact: jeffrey zajac ; 293 boston post road w; #330; marlborough, MA 01752
• MDR Report Key: 16529708
• MDR Text Key: 311210831
• Report Number: 1226572-2023-00019
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V-GO 20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Female