MAUDE Adverse Event Report: SANOFI-AVENTIS TOUJEO SOLOSTAR PEN; INSULIN GLARGINE INJECTION

Lot Number 7F499B

Device Problems Device Expiration Issue (1216); Device Inoperable (1663); Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

Reporter stated that when attempting to inject the needle, resistance was felt and the needle would not penetrate her skin.The device was inoperable and the pen was still filled with medication.Patient also states that, the expiration dates are not concurrent with shipment dates.Two replacements had been sent to her and patient declined, but later accepted them.She is however, not requesting a replacement at this time.

• Brand Name: TOUJEO SOLOSTAR PEN
• Type of Device: INSULIN GLARGINE INJECTION
• Manufacturer (Section D): SANOFI-AVENTIS; 55 corporate drive ; po box 5925; bridge water NJ 08807
• MDR Report Key: 6521867
• MDR Text Key: 73972712
• Report Number: MW5069321
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/01/2018
• Device Lot Number: 7F499B
• Other Device ID Number: NDC0024-5869-03
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 83