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

Model Number MMT-105ELBLNA

Device Problems Computer Software Problem (1112); Material Too Rigid or Stiff (1544)

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

Event Date 03/22/2024

Event Type  malfunction  

Event Description

It was reported to medtronic minimed that the customer experienced dose log/report data inaccuracy, difficult to dial/dose.The customer reported no adverse event.The event involved product(s) mmt-105elblna.Troubleshooting was performed and found that intended dose amount and dose anount recorded in the inpen application greater than 1.0 unit.There was additional resistance experienced when turning dose knob/dial greater than 4 units.No harm requiring medical intervention was reported.The customer will discontinue the use of the inpen.Mmt-105elblna was requested and customer response was the device will be returned.

Manufacturer Narrative

This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.Per visual inspection: no physical damage to cartridge holder or inpen front and back shell was noted.The inpen paired to the commercial app.Inpen failed baseline and wireless functionality.App logbook displayed: 4.5u, 5u, 5u, 5.5u, 5u, 5u, 4u, 3.5u, 4u, 5u.Inpen passed front cap investigation.Base line functionality test and displacement dose accuracy were not performed due to showed there was a pattern wheel misalignment due to an encoder base bond failure.Difficult to dial/dose confirmed.Dose log/report data inaccuracy unable due to failed baseline and wireless functionality.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-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: 19061095
• MDR Text Key: 339612011
• Report Number: 3012822846-2024-00415
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000313
• UDI-Public: (01)000010862088000313(17)240822
• 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 Model Number: MMT-105ELBLNA
• Device Catalogue Number: MMT-105ELBLNA
• Device Lot Number: B1365
• 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: 08/22/2022
• 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: 59 YR