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

Model Number MMT-105NNBLNA

Device Problem Failure to Align (2522)

Patient Problem Hyperglycemia (1905)

Event Date 07/07/2021

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 403 mg/dl.The customer did not state how they treated for the high blood glucose.No harm requiring medical intervention was reported.The insulin pen will be returned for analysis.

• 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: 12136169
• MDR Text Key: 260504742
• Report Number: 3012822846-2021-00576
• 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: Other
• Type of Report: Initial
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• 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: B93UK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2021
• 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: 26 YR