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

Model Number MMT-105NNPKNA

Device Problem Wireless Communication Problem (3283)

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

Event Date 06/22/2023

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the customer was unable to connect his inpen with a mobile application.Troubleshooting was performed. no harm requiring medical intervention was reported.

Manufacturer Narrative

Per visual inspection: no physical damage to cartridge holder or inpen front and back shell was noted.The leadscrew was received 1/4 it's travel.Several attempts were made to pair inpen, every time app displayed ¿inpen not found¿.The inpen does not pair with commercial mobile app.Inpen did not transmit to manufacturing app.Removed injection button and dose detent to expose electronics.Battery and electronics were found corroded.Unable to perform baseline and wireless functionality and displacement dose accuracy.Inpen passed front cap investigation.In conclusion: it was determined the cause of inpen not pairing was caused by fluid intrusion to the battery.Therefore, the customer concern of inpen not pairing to app was 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: justin ellis ; 1223 world trade drive, 100; san diego, CA 92128 ; 7635265677
• MDR Report Key: 17305504
• MDR Text Key: 318898367
• Report Number: 3012822846-2023-01278
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 0000108620880003
• UDI-Public: (01)0000108620880003(17)230414(10)B0048
• 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: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2023
• Device Model Number: MMT-105NNPKNA
• Device Catalogue Number: MMT-105NNPKNA
• Device Lot Number: B0048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 88 KG