MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN MMT-105NNGYNA NOVO NORDISK GRAY; SYRINGE, PISTON

Model Number MMT-105NNGYNA

Device Problems Break (1069); Computer Software Problem (1112); Material Too Rigid or Stiff (1544)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported to medtronic minimed that the customer experienced dose log/report data inaccuracy, difficult to dial/dose, damage (physical or cosmetic).The customer reported no adverse event.The event involved product(s) (b)(6) troubleshooting was performed and customer reported dose knob/dial difficult to turn.Customer reports broken/damaged inpen.Inpen replacment initiated.No harm requiring medical intervention was reported.The customer will discontinue using the device.(b)(6) was requested and customer response was the device will be returned.

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Customer reports: inpen app does not register accurate doses.Dose knob is difficult to dial and stiff.Per visual inspection: no physical damage to cartridge holder or inpen front and back shell was noted.Cartridge holder locks properly in place.The inpen paired to the commercial app.Inpen passed baseline and wireless functionality.App logbook displayed: 15u, 15u, 15u, 15u, 15u, 15u, 15u, 15u, 15u, 15u.Inpen passed displacement dose accuracy.Inpen passed dialing alignment using dose knob zero alignment gage.However, during deconstruction investigation, contact pcba board demonstrated scraping marks around the wheel that rubbed against the dose nut walls causing an intermittent dial while dosing.Inpen passed front cap investigation.In conclusion: inpen passed all required testing.No anomalies were noted and all functions tested ok.Dose log/report data inaccuracy was not confirmed.No mechanical malfunctions noted during testing that could affect insulin delivery.Therefore, the customer concern of difficult to dial/dose could not be confirmed.However, during deconstruction investigation, contact pcba board demonstrated scraping marks around it that rubbed against the dose nut walls causing an intermittent dial while dosing due to possible base bond failure.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: INPEN MMT-105NNGYNA NOVO NORDISK GRAY
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COMPANION MEDICAL INC; 1223 world trade drive, 100; san diego CA 92128
• Manufacturer (Section G): COMPANION MEDICAL INC; 1223 world trade drive, 100; san diego CA 92128
• Manufacturer Contact: lusine boyadzhyan ; 1223 world trade drive, 100; san diego, CA 92128
• MDR Report Key: 18985985
• MDR Text Key: 338754724
• Report Number: 3012822846-2024-00380
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000351
• UDI-Public: (01)000010862088000351(17)251214
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201337
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-105NNGYNA
• Device Catalogue Number: MMT-105NNGYNA
• Device Lot Number: B2062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 73 KG