MAUDE Adverse Event Report: COMPANION MEDICAL INC KIT MMT-105NNBLW1 NOVONORDISK BLUE OUS1; SYRINGE, PISTON

Model Number MMT-105NNBLW1

Device Problems Material Too Rigid or Stiff (1544); Connection Problem (2900)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the customer had a cartridge holder cracked.Troubleshooting was performed.The customer reported the dose knob/dial is difficult to turn.The intended dose amount and amount where difficulty turning was experienced was 1.5.The customer attempted to force the dose knob/dial when difficulty turning was experienced.The intended dose amount and the dose amount recorded in the inpen application are different.No harm requiring medical intervention was reported.It was unknown whether the customer will continue the use of the device.The inpen will not be returned for analysis.

Manufacturer Narrative

Select patient information cannot be provided due to regional privacy regulations.Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.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: KIT MMT-105NNBLW1 NOVONORDISK BLUE OUS1
• 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: 19004033
• MDR Text Key: 338936038
• Report Number: 3012822846-2024-00392
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K201337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-105NNBLW1
• Device Catalogue Number: MMT-105NNBLW1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2024
• 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