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

Model Number	V-GO 20
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A mannkind v-go trainer advised that the family member of a v-go patient called to report that the patient's v-go was changed last night with a new device and the patient's blood sugar started dropping.The patient was given juice but blood sugar did not improve.Device was removed from patient and blood sugar did not improve.911 was called and patient was taken to emergency room.It was reported that the patient's blood sugar was around the 40's.The v-go trainer did say they notified the patient's healthcare professional (hcp).It was reported that the device was available for return to the manufacturer for evaluation.However, to date, the device has not been returned.
Additional Manufacturer Narrative
Adverse event (ae) assessment: ae assessor spoke to v-go trainer and the patient's family member regarding the above complaint.The patient started using the v-go 20 with novolog insulin on (b)(6).Prior to v-go the patient was on 35 units of lantus daily.She checks her glucose levels via finger stick 4-5 times daily.She eats three small meals a day.She was to give 3 clicks per meal, but was only giving one or two clicks.She had covid earlier this year, which lasted 3 weeks and caused a heart attack and congestive heart failure (chf).She changes her device every evening at 8pm which is her bedtime.On the evening of (b)(6) at around 10pm; she called her daughter into her bedroom stating she didn't feel well.The patient was sweating and confused.When her glucose was checked it was 44.She was given juice and candy and the recheck of her glucose had dropped to 42.At that point the daughter removed the v-go device and gave coke and more candy.Her glucose continued to drop down to 40.The squad (ambulance) was called, and the patient was treated by them which then brought her glucose up to 60.Because of her glucose levels and her heart condition the squad decided to transport her to the emergency room (er).Upon arrival at the hospital her sugar rose to 100.She was admitted for observation due to her hypoglycemia and her chf.On the night of the event, she had changed her device at 8pm; she had not given any dinner clicks.She placed it on her abdomen.The daughter saved the device in question and noted that the insulin window showed that half of the insulin was gone after wearing the device for only two hours.However, to date the device has not been returned.The patient has been discharged and is to follow up with her endocrinologist.She is no longer using the v-go device.This is a serious adverse event.It is possible that the device contributed to the event.
Additional Manufacturer Narrative
Device evaluation: one device was received and evaluated for the grey indicator moving too fast complaint.Device#: (b)(6) was received and inspected.The device exhibited no anomalies that could contribute to the reported event.Product engineering verified that the device performed as intended, and the reported event could not be confirmed.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: 16931258
• Report Number: 1226572-2023-00038
• Device Sequence Number: 12442421
• Product Code: LZG
• UDI-Device Identifier: 00385609400032
• UDI-Public: (01)00385609400032(17)250720(10)FG222106
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/25/2025
• Device Model Number: V-GO 20
• Device Catalogue Number: 8560-9400-03
• Device Lot Number: VG222050C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• 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: Hospitalization
• Patient Age: 87 YR
• Patient Sex: Female