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

Model Number V-GO 20

Device Problem Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2023

Event Type  malfunction  

Event Description

The family member of a patient using v-go reported that the patient experienced two v-go's fall off during use.It was reported that the patient may have bumped the device or placed it in a bad spot.The patient was new to the product and in the learning process of use.It was reported that product samples are available for return to the manufacturer for evaluation, however to date, the devices have not been received.

Manufacturer Narrative

Device evaluation: two devices were received and evaluated for the device fell off event complaint.All device functions were tested, and no issue was observed.Due to the used condition of the foam pad, the original adhesion properties could not be verified.The complaint for these devices could not be confirmed.

• 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: 16663085
• MDR Text Key: 312505574
• Report Number: 1226572-2023-00022
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 00385609400032
• UDI-Public: (01)00385609400032(17)250323(10)FG222070
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: V-GO 20
• Device Catalogue Number: 8560-9400-03
• Device Lot Number: FG222070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2022
• 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 Age: 23 YR
• Patient Sex: Female