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

Model Number MMT-105NNBLNA

Device Problem Obstruction of Flow (2423)

Patient Problem Hyperglycemia (1905)

Event Date 03/23/2021

Event Type  Injury  

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

The customer reported via phone call that they experienced high blood glucose.The blood glucose reading was 400 mg/dl.The customer treated their high blood glucose with manual injections.Customer primed the insulin pen multiple times and replaced the needle, but insulin did not exit.No harm requiring medical intervention was reported.The customer¿s blood glucose at the time of the call was 163 mg/dl.The insulin pen will be returned for analysis.

Manufacturer Narrative

Serial number: n/a software version: n/a color: blue battery life remaining:

• 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
• MDR Report Key: 11572767
• MDR Text Key: 242409523
• Report Number: 3012822846-2021-00089
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-105NNBLNA
• Device Catalogue Number: MMT-105NNBLNA
• Device Lot Number: B94KU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR