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	Hypoglycemia (1912); Confusion/ Disorientation (2553)
Date of Event	05/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Adverse event (ae) assessment: ae assessor spoke with the long term v-go 20 user.She uses humalog in her device.She normally changes it around 4-4:30pm.Her case is complicated by gastroparesis.She has severe gut issues which make the timing of her insulin use and the meal intake difficult to match.She states she doesn't really eat meals.She eats small amounts; frequently.She will give 2 or 3 clicks.She does not use a continuous glucose monitor (cgm), but tests by finger sticks 5 times a day.On may 12th she had a stressful, tense day visiting with family.She cannot recall if she even ate that day.When family left she became confused and sweaty.She checked her glucose, which was 52.She consumed 3 orange gel candy slices and waited 7 minutes, she retested, and the result was the same 52.She did this a total of 7 times, all with the same glucose result of 52.She removed the v-go device after the third time.She called 911 and the emts gave her glucose gel.She was stabilized in the ambulance and taken to the er.Upon discharge from the er her glucose was 310.She has a follow up visit scheduled with her endocrinologist.She has multiple other medical issues which she did not name.Gastroparesis makes it difficult to dose insulin correctly.It is unlikely that this serious adverse event was caused by the device.
Event or Problem Description
The patient reported that their blood sugar got down to 52 on (b)(6) 2024.She called the ambulance because she was not able to get her blood sugar up on her own by chewing candy.The patient reported that it might have been user error (she may have lost count of how many clicked she pushed for bolus).The device is not available for return to the manufacturer for evaluation.

• 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: 19459318
• Report Number: 1226572-2024-00024
• Device Sequence Number: 20812655
• Product Code: LZG
• UDI-Device Identifier: 00385609400032
• UDI-Public: (01)00385609400032(17)260508(10)FG223090
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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: 05/10/2026
• Device Model Number: V-GO 20
• Device Lot Number: VG223059B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2026
• 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: 79 YR
• Patient Sex: Female