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

Model Number MMT-105ELPKNA

Device Problem Computer Software Problem (1112)

Patient Problem Insufficient Information (4580)

Event Date 12/30/2021

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the dial button was not twisting properly.Customer stated that the inpen app was not recording the exact doses dialed.The difference between the dose intended and dose logged was not always 0.5 units.No harm requiring medical intervention was reported.Troubleshooting was performed, the customer will continue the use of device.

Manufacturer Narrative

Serial number: n/a, software version: n/a, color: pink, battery life remaining: n/a, per visual inspection: no cosmetic damage noted.Customer reports: the dial button is not twisting properly.The inpen feels broken inside.Inpen app is not recording the exact doses dialed on the inpen.Several attempts were made to pair inpen, every time app displayed dose doesn't match and inpen not found.The inpen does not pair with commercial mobile app.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 injection 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.In conclusion: it was determined that pairing anomaly and the customer complaint of hard to turn the inpen dial is confirmed.However, unable to verify dose log anomalies complaint due to misalign encoder pattern wheel rotating and traveling against the walls of the dose nut.(b)(4).

• Brand Name: INPEN MMT-105ELPKNA ELI LILY PINK
• 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: 13665645
• MDR Text Key: 289265042
• Report Number: 3012822846-2022-00194
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000337
• UDI-Public: (01)000010862088000337(17)230503
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/03/2023
• Device Model Number: MMT-105ELPKNA
• Device Catalogue Number: MMT-105ELPKNA
• Device Lot Number: B0104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Date Manufacturer Received: 02/18/2022
• 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: 30 YR
• Patient Sex: Male