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

Model Number MMT-105NNGYNA

Device Problem Failure to Align (2522)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.

Event Description

Information received by medtronic indicated that the inpen cap were not stay attached insulin.No harm requiring medical intervention was reported.The inpen was 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: 13340761
• MDR Text Key: 286639130
• Report Number: 3012822846-2022-00050
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000351
• UDI-Public: (01)000010862088000351(17)230329
• 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: 01/25/2022

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 Expiration Date: 03/29/2023
• Device Model Number: MMT-105NNGYNA
• Device Catalogue Number: MMT-105NNGYNA
• Device Lot Number: B95DF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 01/25/2022
• 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: 59 YR
• Patient Sex: Male