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

Model Number MMT-105NNGYNA

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2021

Event Type  malfunction  

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.

Event Description

Information received by medtronic indicated that the insulin pen had a leadscrew anomaly. Customer¿s blood glucose was unknown. 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: 13102114
• Report Number: 3012822846-2021-00915
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000351
• UDI-Public: (01)000010862088000351(17)230521
• 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,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/21/2023
• Device Model Number: MMT-105NNGYNA
• Device Catalogue Number: MMT-105NNGYNA
• Device Lot Number: B0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2022
• 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: Unkown
• Patient Age: 60 YR
• Patient Sex: No Answer Provided
• Patient Weight: 0 KG