MAUDE Adverse Event Report: LAKE REGION MEDICAL NAVIPRO; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	M00556220
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The wire is 'stuck' in the packaging.Multiple attempts were made to free the device from packaging.

• Brand Name: NAVIPRO
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): LAKE REGION MEDICAL; 100 fordham road; bldg. c; wilmington MA 01887
• MDR Report Key: 15770144
• Report Number: 15770144
• Device Sequence Number: 15080193
• Product Code: OYC
• UDI-Device Identifier: 08714729848233
• UDI-Public: 08714729848233
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/27/2022
• Report Date (Section F): 10/27/2022

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 Model Number: M00556220
• Device Lot Number: JRZ7261313
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White
• Date Report Sent to FDA: 10/27/2022