MAUDE Adverse Event Report: MEDTRONIC MINIMED INPEN (NOVOLOG OR FIASP) BLUE; INJECTOR, PEN

Lot Number	B0361
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Hcp lea stated patient received the wrong pen; patient cannot use the device for his insulin and it is not what was ordered by the hcp.No further details were provided.

• Brand Name: INPEN (NOVOLOG OR FIASP) BLUE
• Common Device Name: INJECTOR, PEN
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 15066926
• Report Number: MW5110967
• Device Sequence Number: 17336615
• Product Code: NSC
• UDI-Device Identifier: 62088-0000-34
• UDI-Public: 62088-0000-34
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/09/2023
• Device Lot Number: B0361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2022
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male