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

Model Number	V-GO 20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Hyperglycemia (1905)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Adverse event (ae) assessment: ae assessor spoke with the patient who reported that both the bolus button and the needle retraction button stuck on each of two v-go.While using the v-go device, the patient reports that their blood glucose (bg) level is generally 100-189, 190 mg/dl, aic 6.7%, taking 1 click if bg is in the 200s, 2 clicks if bg is 300s; she does not take bolus clicks with meals.When bolus button was stuck and would not allow the delivery button to deliver a click of insulin bg rose to over 400 mg/dl (on her continuous glucose monitor) and rechecked on her glucometer at over 500 mg/dl.She experienced thirst and tiredness.She decided to remove the v-go, but the needle retraction button stuck too.She put her finger under the adhesive all around the v-go.When the adhesive was lifted off the skin, she gently pulled the v-go straight off her tissue.There was a drop of blood on the needle, but the tissue was not injured.She placed a new v-go on another site and within an hour her blood glucose came down to 420, then 380 and then 200s mg/dl.This sequence of events happened with two different v-go.Specific event dates were not provided.For a backup plan the patient has a supply of syringes and insulin should she need to take insulin by injection to improve her blood sugar.She is in contact with her healthcare practitioner (hcp) for medical and blood glucose management.This complaint could be serious with reoccurrence due to the blood glucose over 400 mg/dl with symptoms of thirstiness and tiredness.She is returning one v-go for a technical review.There is a temporal relationship between the v-go use, the bolus button sticking and the high blood sugar.However, the patient was wearing a continuous glucose monitor and did not take action until the blood glucose was over 400 mg/dl.
Event or Problem Description
The patient reported that the v-go needle button was stuck and caused hyperglycemia.It was reported that a device is available for return to the manufacturer for evaluation.However, to date, has not been received.
Additional Manufacturer Narrative
Device evaluation: one device was received and evaluated for the bolus button locked < 18 clicks complaint.Device #(b)(6) was inspected and the functions were tested.The testing verified that the device operated as intended.The device exhibited no anomaly that could contribute to the reported event.The complaint about this device could not be confirmed.

• Brand Name: V-GO DISPOSABLE INSULIN DELIVERY DEVICE
• Common Device Name: 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: 18440099
• Report Number: 1226572-2023-00139
• Device Sequence Number: 18034041
• Product Code: LZG
• UDI-Device Identifier: 00385609400032
• UDI-Public: (01)00385609400032(17)250922(10)FG222133
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K103825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/15/2025
• Device Model Number: V-GO 20
• Device Lot Number: VG222081C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female