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

Model Number MMT-105NNBLNA

Device Problem Computer Software Problem (1112)

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

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

Software version: 3.8.5.Color: blue.Battery life remaining: < 3 months.First bond date: mar.18, 2023 initial battery %: 86.Last bond date: dec.22, 2023 last battery %: 82.User mobile device: iphone 14 ios: 16.6.Testing mobile device: iphone 11 ios: 16.7.1.Customer reports: dose log inaccuracy by 0.5u.Per visual inspection: cartridge holder is missing.No physical damage to inpen front and back shell was noted.Test 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.Inpen passed front cap investigation using test cartridge holder.In conclusion: inpen passed all required testing.No anomalies were noted and all functions tested ok.Dose log/report data inaccuracy was not confirmed.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Information received by medtronic indicated that the customer reported that the inpen app was not recording the exact doses dialed on the inpen.Troubleshooting was performed.No harm requiring medical intervention was reported.The customer will discontinue the use of the inpen and it will be returned for analysis.

Manufacturer Narrative

Customer reports: dose log inaccuracy by 0.5u.Per visual inspection: cartridge holder is missing.No physical damage to inpen front and back shell was noted.Test 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.Inpen passed front cap investigation using test cartridge holder.In conclusion: inpen passed all required testing.No anomalies were noted and all functions tested ok.Dose log/report data inaccuracy was not confirmed.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: INPEN MMT-105NNBLNA NOVO NORDISK BLUE
• 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: 18482022
• MDR Text Key: 332554743
• Report Number: 3012822846-2024-00038
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000344
• UDI-Public: (01)000010862088000344(17)230823
• 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: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/23/2023
• Device Model Number: MMT-105NNBLNA
• Device Catalogue Number: MMT-105NNBLNA
• Device Lot Number: B0536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2023
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 51 KG