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

Model Number MMT-105ELGYNA

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 01/31/2022

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the inpen cartridge holder was damaged.Customer reported dose dial was not misaligned.No harm requiring medical intervention was reported.The customer will discontinue use of the device.

Manufacturer Narrative

Battery life remaining: 3 months.Per visual inspection: broken off piece at the cartridge holder.Customer reports: the cartridge holder is damaged.Unit paired successfully to commercial app.Inpen received with leadscrew halfway of the travel.Re-wound screw.No drag was observed, the screw was not bent, advanced when dosage knob was pressed dialing a dosage and retracted appropriately.No resistance was observed when dosing without a cartridge installed.The screw advanced every time 30.0u was dialed and dosed until the screw reached max extension.In conclusion: inpen received with broken off piece at the cartridge holder.The cartridge holder did not lock in place.The customer complaint of physical damage was confirmed.(b)(4).

• 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: 13630004
• MDR Text Key: 289071232
• Report Number: 3012822846-2022-00173
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000320
• UDI-Public: (01)000010862088000320
• 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: 03/01/2022

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 Model Number: MMT-105ELGYNA
• Device Catalogue Number: MMT-105ELGYNA
• Device Lot Number: A92LJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/01/2022
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 62 KG