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 02/04/2022

Event Type  malfunction  

Manufacturer Narrative

Color: grey.Battery life remaining: <10 months.Per visual inspection: no physical damage noted.Customer reports: dial its difficult to turn and no insulin comes out.The inpen paired to the commercial app with 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 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 insulin pen insulin was coming out when tries to prime.No harm requiring medical intervention was reported.The customer will discontinue to use the device.

• 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: 13789877
• MDR Text Key: 292194568
• Report Number: 3012822846-2022-00242
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000320
• UDI-Public: (01)000010862088000320(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: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• 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-105ELGYNA
• Device Catalogue Number: MMT-105ELGYNA
• Device Lot Number: B0110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Date Manufacturer Received: 02/28/2022
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 70 KG