MAUDE Adverse Event Report: SANOFI AVENTIS TOUJEO SOLO STR; INSULIN GLARGINE INJECTION PEN

Lot Number	6F311A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Other
Event or Problem Description
Reporter stated the depression button on the injection pen gets stuck and it becomes inoperable.She said upon removal of the pen, the needle broke off and caused the insulin to leak.As a result the insulin did not get delivered.The reporter suspected there could be a compatibility issue between the injection pen and the needle.
Event or Problem Description
Additional information received on 12/13/2016 from reporter for report number mw5066457.The reporter stated that she contacted (b)(6) to complain about the ongoing problem about her insulin pen from sanofi.She stated it is quality and workmanship problem.

• Brand Name: TOUJEO SOLO STR
• Common Device Name: INSULIN GLARGINE INJECTION PEN
• Manufacturer (Section D): SANOFI AVENTIS
• MDR Report Key: 6140739
• Report Number: MW5066457
• Device Sequence Number: 17870707
• Product Code: NSC
• Initial Reporter State: CT
• 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,Followup
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 04/01/2018
• Device Lot Number: 6F311A
• Other Device ID Number: NDC:0024-5869-03
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2016
• Supplement Report FDA Received Date: 12/13/2016
• Patient Sequence Number: 1
• Patient Weight: 87