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); Anxiety (2328); Shaking/Tremors (2515)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Adverse event (ae) assessment: ae assessor spoke with the patient for further investigation of the case.The patient is using vgo 20 with up to 8 clicks during the day and often removes the v-go at night.He also may remove the v-go during exercise.The patient reported having bg at the level of below 50 mg/dl once with symptoms of nervousness, shakiness, and anxiety.The patient stated the continuous glucose monitor does not read below 50.He also said he has had bg levels in the 63-65 mg/dl range.He manages them with oral carbohydrates.The blood glucose improves but how long it took is unknown.He indicated he always has oral carbohydrates with him which was advocated during the diabetes education that he received.His a1c has improved from a 7.2% to 6.2% since using v-go.The endocrinologist has recommended a different insulin delivery device to prevent low blood glucose level.It's possible the v-go contributed to lower bg levels but more likely its due to the patient requiring less than 20 units of basal insulin for 24 hours.The v-go 20 contains too much basal insulin for the patient's needs which both the patient and his endocrinologist acknowledge.Due to the bg level at 50 or below this case could be serious with reoccurrence.The patient is in contact with his endocrinologist for medical and bg management.Device evaluation: one device was received and evaluated for the complaint regarding the unknown device issue/hypoglycemia.Device #053185-a was inspected, and the device functions were tested.The testing confirmed that no anomaly could contribute to the event.The complaint for this device could not be confirmed.
Event or Problem Description
It was reported that the patient experienced hypoglycemia having blood glucose (bg) at the level below 50 mg/dl once with symptoms of nervousness, shakiness, and anxiety while wearing v-go.It was reported that the device is 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: 18143400
• Report Number: 1226572-2023-00130
• Device Sequence Number: 6588370
• Product Code: LZG
• UDI-Device Identifier: 00385609400032
• UDI-Public: (01)00385609400032(17)250922(10)FG222133
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/27/2023

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: 09/22/2025
• Device Model Number: V-GO 20
• Device Lot Number: FG222133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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 Sex: Male