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

Model Number MMT-105NNPKNA

Device Problems Computer Software Problem (1112); Patient Device Interaction Problem (4001)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

Per visual inspection: injection foot is missing.Front shell does not stay attached.No physical damage to cartridge holder or inpen 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 failed dialing alignment.Two tick marks appear in dose window when zero mark is appears in the alignment gage window.Performed leadscrew reset torque test.Inpen passed and is within specification (ccw: 3.75 ozf-in).Inpen failed front cap investigation.Inpen front shell does not fit securely onto cartridge holder due to snap arm being cracked / broken.Pending further investigation performed in san diego location.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 has reported inpen app is not recording the exact doses dialed on the inpen and the dose knob loose.Troubleshooting was performed and the issue was not resolved.No harm requiring medical intervention was reported.The customer will discontinue the use of the device and the inpen will be returned for analysis.

Manufacturer Narrative

Customer reports: dose log inaccuracy and leadscrew anomaly.Per visual inspection: injection foot is missing.Front shell does not stay attached.No physical damage to cartridge holder or inpen 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 failed dialing alignment.Two tick marks appear in dose window when zero mark is appears in the alignment gage window.Performed leadscrew reset torque test.Inpen passed and is within specification (ccw: 3.75 ozf-in).Inpen failed front cap investigation.Inpen front shell does not fit securely onto cartridge holder due to snap arm being cracked / broken.Pending further investigation performed in san diego location.In conclusion: displacement dose accuracy test fixture is operational in northridge.Testing to be performed in nr facility.Inpen passed displacement dose accuracy test.Dose log/report data inaccuracy not confirmed and leadscrew anomaly 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-105NNPKNA NOVO NORDISK PINK
• 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: 18159348
• MDR Text Key: 328396553
• Report Number: 3012822846-2023-01885
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000368
• UDI-Public: (01)000010862088000368(17)241020
• 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: 01/01/2024

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-105NNPKNA
• Device Catalogue Number: MMT-105NNPKNA
• Device Lot Number: B1496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 81 KG