MAUDE Adverse Event Report: SANOFI LANTUS SOLOSTAR INSULIN INJECTION PEN; INJECTOR, PEN

Lot Number	4F9786A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Caller stated that he purchased five (5) sets of insulin pen.Two of the pens knob cannot be turned to infuse insulin so he cannot use them due to this mechanical issue.He believed this pens are defective.He called the manufacturer and was sent a returned postal envelope to return both pens and he did.About a month later he received a letter from the manufacturer acknowledging that the pens are received and will investigate the matter and get back to him.Caller is disappointed because the manufacturer are not taking responsibility for their defective product.Reference report: mw5170349.

• Brand Name: LANTUS SOLOSTAR INSULIN INJECTION PEN
• Common Device Name: INJECTOR, PEN
• Manufacturer (Section D): SANOFI
• MDR Report Key: 22019392
• Report Number: MW5170350
• Device Sequence Number: 9072070
• Product Code: NSC
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

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
• Operator of Device: Lay User/Patient
• Device Lot Number: 4F9786A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White