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

Model Number MMT-105ELGYNA

Device Problem Computer Software Problem (1112)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported to medtronic minimed that the customer experienced log inaccuracy occurring when the inpen.The customer reported no adverse event.The event involved product(s) mmt-105elgyna.Troubleshooting was performed.No harm requiring medical intervention was reported.The customer will discontinue the use of the device.Mmt-105elgyna was requested and customer response was the device will be returned.

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 received with damage/broken injection foot.The inpen paired to the commercial app.Inpen dialing alignment passed.Unable to perform inpen passed baseline and wireless functionality and displacement dose accuracy due to broken off injection foot.Inpen passed front cap investigation.Dose log/report data inaccuracy confirmed due to damage/broken off injection foot.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-105ELGYNA ELI LILY GRAY
• 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: 19060385
• MDR Text Key: 340395917
• Report Number: 3012822846-2024-00414
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000320
• UDI-Public: (01)000010862088000320(17)231026
• 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: 04/08/2024

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 Expiration Date: 10/26/2023
• Device Model Number: MMT-105ELGYNA
• Device Catalogue Number: MMT-105ELGYNA
• Device Lot Number: B0803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2024
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2021
• 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: 76 YR
• Patient Sex: Female