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

Model Number MMT-105ELGYNA

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 11/26/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Serial number: n/a; software version: n/a ; color: grey; battery life remaining: n/a.Customer reports: the dial is very hard to push past 4 units, if he turns really hard it will go past 4 but if he tries to dispense insulin nothing will come out.Per visual inspection: missing dose window.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.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.A battery test was performed, and battery measured 3.0 volts.In conclusion: it was determined that pairing anomaly and the customer complaint of hard to turn the inpen, hard to dial, hard to push to give insulin was confirmed due to encoder pattern wheel rotating and traveling against the walls of the dose nut.

Event Description

Information received by medtronic indicated that the in pen had hard to push past 4 unit and customer stated they watched lead screw.No harm requiring medical intervention was reported.The insulin pump was returned for analysis.

• 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: 13448528
• MDR Text Key: 287531069
• Report Number: 3012822846-2022-00083
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000320
• UDI-Public: (01)000010862088000320(17)230419
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/19/2023
• Device Model Number: MMT-105ELGYNA
• Device Catalogue Number: MMT-105ELGYNA
• Device Lot Number: B0061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Date Manufacturer Received: 01/20/2022
• 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: 52 YR