MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN MMT-105NNBLNA NOVO NORDISK BLUE SYRINGE, PISTON

Model Number MMT-105NNBLNA

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 11/13/2021

Event Type  malfunction  

Event Description

The information received by medtronic indicated that the insulin pen was not dispensing insulin. They stated that insulin pen will get stuck and not deliver the entire intended amount, it went 1,2,3 and quit. They the removed the cartridge holder and turned the dial to 5 units, when pressing the button to dispense, insulin pen will only move the dial down to 2 units and not 0 like it should, stated they had to press very hard to move it. He tried 30 units and insulin pen only let him push it to 6 units. No harm requiring medical intervention was reported. The insulin pen will be returned for analysis.

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.

• Brand Name: INPEN MMT-105NNBLNA NOVO NORDISK BLUE
• 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: 12879691
• MDR Text Key: 282553806
• Report Number: 3012822846-2021-00841
• Device Sequence Number: 1
• Product Code: FMF
• 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

• Type of Report: Initial
• Report Date: 12/20/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: MMT-105NNBLNA
• Device Catalogue Number: MMT-105NNBLNA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2021
• 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: Unkown