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

Model Number MMT-105NNBLNA

Device Problems Computer Software Problem (1112); Connection Problem (2900); Moisture or Humidity Problem (2986); Wireless Communication Problem (3283)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the customer reported that the inpen had a moisture damage as the customer dropped it in the water.Troubleshooting was performed and the customer also reported that dose knob, dial was slipping for greater than 1.0 unit.The customer also alleged that the pen info was not transferring to the app.No harm requiring medical intervention was reported.The customer will discontinue to use the inpen and the inpen will be returned for analysis.

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.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.

Manufacturer Narrative

Per visual inspection: no physical damage to cartridge holder or inpen front and back shell was noted.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.Performed battery investigation and battery measured 0.947v.Battery and electronics were found corroded.Unable to perform baseline wireless/functionality test or displacement dose accuracy test.Inpen failed front cap investigation.Inpen front shell does not fit securely onto cartridge holder due to small snap arm being cracked / broken.Cracked cartridge holder was noted during visual inspection.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.Physically damaged cartridge holders can affect insulin delivery.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: 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: 18883772
• MDR Text Key: 337422249
• Report Number: 3012822846-2024-00324
• Device Sequence Number: 1
• Product Code: FMF
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-105NNBLNA
• Device Catalogue Number: MMT-105NNBLNA
• Device Lot Number: B1769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2023
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 82 KG