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

Model Number MMT-105NNBLW1

Device Problem Computer Software Problem (1112)

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

Event Date 03/25/2024

Event Type  malfunction  

Event Description

It was reported to medtronic minimed that the customer experienced dose log/report data inaccuracy.The customer reported no adverse event.The event involved product(s) mmt-105nnblw1.Troubleshooting was performed and found that the customer reported unexplained false doses.The inpen has registered the doses in the application that has not given by the customer.Unable to resolve with existing troubleshooting or labeled instructions, issue escalated.No harm requiring medical intervention was reported.The customer will discontinue using the inpen.Product return for mmt-105nnblw1 is not expected.

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: 19141735
• MDR Text Key: 341141064
• Report Number: 3012822846-2024-00430
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 04/19/2024

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: MMT-105NNBLW1
• Device Catalogue Number: MMT-105NNBLW1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• 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