MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN MMT-105ELBLNA ELI LILY BLUE; SYRINGE, PISTON

Model Number MMT-105ELBLNA

Device Problem Computer Software Problem (1112)

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

Event Date 09/22/2023

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the customer reported inpen app does not document correct doses and inpen app is not recording the exact doses dialed on the inpen.Troubleshooting was performed and it was reported inpen color is blue and dose knob/dial is not difficult to turn and the difference between the dose intended and dose logged always 0.5 units.No harm requiring medical intervention was reported.The customer discontinued using the device and the device was returned for analysis.

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.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 front cap investigation.Pending further investigation performed in san diego location.In conclusion: per san diego analysis: inpen passed base line functionality test and displacement dose accuracy.Inpen failed dose knob alignment.Inpen baseline and wireless functionality.App logbook displayed: 15,15,15,15,15,15,15,15,15,15.Paired to commercial app using 10.5 units.Due to dialing misalignment between ~10.5-15u the pt may have dosed the incorrect amount.Therefore, dose log inaccuracy was not confirmed.However, dialing misalignment 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-105ELBLNA ELI LILY 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: 18180190
• MDR Text Key: 328620839
• Report Number: 3012822846-2023-01903
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000313
• UDI-Public: (01)000010862088000313(17)231214
• 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: 11/21/2023

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 Expiration Date: 12/14/2023
• Device Model Number: MMT-105ELBLNA
• Device Catalogue Number: MMT-105ELBLNA
• Device Lot Number: B0929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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: 75 YR
• Patient Sex: Female