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

Model Number MMT-105ELGYNA

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/07/2022

Event Type  malfunction  

Event Description

Information received by medtronic indicated that inpen was damaged.Customer also stated that inpen was not working.No harm requiring medical intervention was reported.Troubleshooting was successfully performed; however, the customer will discontinue use of the device.Troubleshooting was performed.The inpen was returned for analysis.

Manufacturer Narrative

Serial number: (b)(4); software version: 3.8.5; color: grey; battery life remaining: <6 months; per visual inspection: scratched casing and debris under dosing window.Customer reports: unspecified damage that is inside the inpen.Unit paired successfully to commercial app with a small pairing dose.The inpen screw retracts when dialing and advances when turning dose knob and high resistance while dispensing and dialing noted.Hard to dial more than 4 units.The dose button was removed and no dust / debris under the dose button or dose knob noted.Inpen was cut open and after inspection it was found that the encoder pattern wheel tabs rotating and traveling off the keyed slots of dose nut guides.Encoder pattern wheel should never rotate.This causes an unexpected travel of the encoder pattern wheel creating resistance to dial and dispensing.Also, contamination build up found caused by encoder wheel tabs rubbing at the walls of the dose nut.In conclusion: the customer complaint of physical damage is confirmed.The hard to turn the inpen, hard to dial, hard to push to give insulin is due to encoder pattern wheel rotating and traveling against the walls of the dose nut.

• 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: tricha miles ; 1223 world trade drive, 100; san diego, CA 92128 ; 7635140379
• MDR Report Key: 13691571
• MDR Text Key: 289319826
• Report Number: 3012822846-2022-00206
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000320
• UDI-Public: (01)000010862088000320(17)230406
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2022

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: 04/06/2023
• Device Model Number: MMT-105ELGYNA
• Device Catalogue Number: MMT-105ELGYNA
• Device Lot Number: B0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 230