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

Model Number MMT-105NNPKNA

Device Problem Computer Software Problem (1112)

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

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

Per visual inspection: no physical damage to cartridge holder or inpen front and back shell was noted.Cartridge holder locks properly in place.Inpen paired with commercial mobile app with small dose.Received inpen [ 1/4 ] of travel.Performed encoder bond investigation and found that the encoder pattern wheel tabs rotating and traveling off the keyed slots of dose nut guides.Encoder pattern wheel should never rotate.This causes an unexpected travel of the encoder pattern wheel creating resistance to dial and dispensing.Also, plastic shavings contamination builds up found caused by encoder wheel tabs rubbing at the walls of the dose nut.Abrasions only at the top section of the dose nut.Unable to perform baseline/wireless functionality and displacement dose accuracy test.Performed leadscrew reset torque test.Inpen passed and is within specification (ccw: 5.70ozf-in).Inpen passed front cap investigation.In conclusion: it was determined from destructive analysis that the difficult to dial/dose was caused by a pattern wheel misalignment due to an encoder base bond failure.This can affect insulin delivery.Unable to confirm accurate doses do not register in the app due to difficult to dial due to pattern wheel misalignment.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.

Event Description

Information received by medtronic indicated that customer reported inpen app was not recording the exact doses dialed on the inpen.Troubleshooting was performed.No harm requiring medical intervention was reported.The customer discontinued using the device and device was returned for analysis.

• 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: 18957001
• MDR Text Key: 338322806
• Report Number: 3012822846-2024-00370
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000368
• UDI-Public: (01)000010862088000368(17)230624
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/24/2023
• Device Model Number: MMT-105NNPKNA
• Device Catalogue Number: MMT-105NNPKNA
• Device Lot Number: B0309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2021
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 100 KG