LANTUS INSULIN PEN 40 UNITS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for LANTUS INSULIN PEN 40 UNITS manufactured by Sanofi-aventis U.s. Llc.

Event Text Entries

[183739226] Reporter said her insulin pen button does not click, it does not go down as if it is stuck. Reporter said she received 3 boxes that contain 5 per box. Out of the 15 pens only 3 of them worked.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093719
• MDR Report Key: 9828912
• Date Received: 2020-03-12
• Date of Report: 2020-03-12
• Date of Event: 2020-03-11
• Date Added to Maude: 2020-03-13
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: LANTUS INSULIN PEN 40 UNITS
• Generic Name: INJECTOR, PEN
• Product Code: NSC
• Date Received: 2020-03-12
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SANOFI-AVENTIS U.S. LLC

Device Sequence Number: 2

• Brand Name: LANTUS INSULIN PEN 40 UNITS
• Generic Name: INJECTOR, PEN
• Product Code: NSC
• Date Received: 2020-03-12
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: SANOFI-AVENTIS U.S. LLC

Device Sequence Number: 3

• Brand Name: LANTUS INSULIN PEN 40 UNITS
• Generic Name: INJECTOR, PEN
• Product Code: NSC
• Date Received: 2020-03-12
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: SANOFI-AVENTIS U.S. LLC

Device Sequence Number: 4

• Brand Name: LANTUS INSULIN PEN 40 UNITS
• Generic Name: INJECTOR, PEN
• Product Code: NSC
• Date Received: 2020-03-12
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: SANOFI-AVENTIS U.S. LLC

Device Sequence Number: 5

• Brand Name: LANTUS INSULIN PEN 40 UNITS
• Generic Name: INJECTOR, PEN
• Product Code: NSC
• Date Received: 2020-03-12
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: SANOFI-AVENTIS U.S. LLC

Device Sequence Number: 6

• Brand Name: LANTUS INSULIN PEN 40 UNITS
• Generic Name: INJECTOR, PEN
• Product Code: NSC
• Date Received: 2020-03-12
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: SANOFI-AVENTIS U.S. LLC

Device Sequence Number: 7

• Brand Name: LANTUS INSULIN PEN 40 UNITS
• Generic Name: INJECTOR, PEN
• Product Code: NSC
• Date Received: 2020-03-12
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 7
• Device Event Key: 0
• Manufacturer: SANOFI-AVENTIS U.S. LLC

Device Sequence Number: 8

• Brand Name: LANTUS INSULIN PEN 40 UNITS
• Generic Name: INJECTOR, PEN
• Product Code: NSC
• Date Received: 2020-03-12
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 8
• Device Event Key: 0
• Manufacturer: SANOFI-AVENTIS U.S. LLC

Device Sequence Number: 9

• Brand Name: LANTUS INSULIN PEN 40 UNITS
• Generic Name: INJECTOR, PEN
• Product Code: NSC
• Date Received: 2020-03-12
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 9
• Device Event Key: 0
• Manufacturer: SANOFI-AVENTIS U.S. LLC

Device Sequence Number: 10

• Brand Name: LANTUS INSULIN PEN 40 UNITS
• Generic Name: INJECTOR, PEN
• Product Code: NSC
• Date Received: 2020-03-12
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 10
• Device Event Key: 0
• Manufacturer: SANOFI-AVENTIS U.S. LLC

Device Sequence Number: 11

• Brand Name: LANTUS INSULIN PEN 40 UNITS
• Generic Name: INJECTOR, PEN
• Product Code: NSC
• Date Received: 2020-03-12
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 11
• Device Event Key: 0
• Manufacturer: SANOFI-AVENTIS U.S. LLC

Device Sequence Number: 12

• Brand Name: LANTUS INSULIN PEN 40 UNITS
• Generic Name: INJECTOR, PEN
• Product Code: NSC
• Date Received: 2020-03-12
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 12
• Device Event Key: 0
• Manufacturer: SANOFI-AVENTIS U.S. LLC

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-12