MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN MMT-105NNGYNA NOVO NORDISK GRAY; SYRINGE, PISTON

Model Number MMT-105NNGYNA

Device Problem Wireless Communication Problem (3283)

Patient Problem Insufficient Information (4580)

Event Date 12/31/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer reports: inpen not connecting pairing.Per visual inspection: missing cartridge holder and cap.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.Lead screw received fully re-wound.The inpen screw retracts when dialing and advances when turning dose knob.Unable to perform functional test due to lead screw anomaly.In conclusion: the customer complaint of inpen not pairing was confirmed.Pending further analysis that will be perform in san diego location.

Event Description

Information received by medtronic indicated that insulin pen was not connecting.Customer tried shutting off and uninstalling, then reinstalling but did not work.Troubleshooting was performed.The insulin pen pairing was no successful.No harm requiring medical intervention was reported.The insulin pen will be returned for analysis.

• Brand Name: INPEN MMT-105NNGYNA NOVO NORDISK 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: 13450702
• MDR Text Key: 287579193
• Report Number: 3012822846-2022-00085
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000351
• UDI-Public: (01)000010862088000351(17)230824
• 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: 02/04/2022

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: 08/24/2023
• Device Model Number: MMT-105NNGYNA
• Device Catalogue Number: MMT-105NNGYNA
• Device Lot Number: B0546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Date Manufacturer Received: 02/02/2022
• 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: 36 YR
• Patient Sex: Male