MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA CHAMPAGNE; FOR TREATMENT PURPOSES

Model Number MS9663

Device Problem Failure to Align (2522)

Patient Problems Stroke/CVA (1770); Neuropathy (1983)

Event Type  malfunction  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.

Event Description

(b)(4) this spontaneous case, reported by a consumer, who contacted the company to report a product complaint with adverse event, concerns an adult caucasian female patient, (b)(6).The medical history included a cerebrovascular accident (cva) in 2006.Concomitant medications: insulin glargine for unknown indication.The patient received human insulin nph (rdna origin) (humulin n) cartridge, 16 iu at night, subcutaneously, for type ii diabetes with complications and glucose control and beginning in (b)(6) 2012.Human insulin nph was delivered via humapen luxura (champagne).In 2014, approximately two years after started human insulin nph treatment, the patient was diagnosed with neuropathy.The corrective treatment and laboratorial exams were not provided and the outcome for neuropathy was not recovered.In (b)(6) 2015, the patient experienced a cerebrovascular accident (cva) with loss of the movement of the left arm and was hospitalized for one week.In the hospital, the patient received an unspecified treatment, the laboratorial exams were not provided and she recovered from cva in (b)(6) 2015.On an unspecified date, after started human insulin nph via humapen luxura champagne (lot 1202b01/(b)(4)), the pen was deregulated, reported as the injection button was not going to the end when pressed and the pen was misaligned with the number zero.In addition, it was reported the patient used the reported device since (b)(6) 2012 and stored the pen on refrigerator.The status of human insulin nph treatment was ongoing.The consumer reporter did not provide any relatedness opinion.The patient was the user of the device.Training status was not provided.General and suspect device duration of use was not provided.The return of the pen was expected.Update 22jan2016: additional information received on 19jan2016 from the global product complaint database updated the device to a humapen luxura (champagne); updated the malfunction field to yes/cirm which updated the device to suspect; added non serious no adverse event to associated to the device; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements.Please refer to update statement dated 29feb2016.No further follow up is planned.Evaluation summary a female patient reported that the injection button of her humapen luxura was not going to the end when pressed and the pen was misaligned with the number zero.The device was not associated with an adverse event.The device was not returned to the manufacturer for investigation (batch (b)(4), manufactured february 2012).The narrative may suggest the presence of a known malfunction (barrel misalignment).Since the device was not returned, the malfunction could not be confirmed.Malfunction unknown.A complaint history review of this batch did not identify any atypical trends with regard to barrel misalignment.All humapen luxura devices are assessed for dose number alignment during and at the end of the manufacturing process, which also ensures barrel alignment.There is no evidence of improper use or storage.

Event Description

(b)(4) this spontaneous case, reported by a consumer, who contacted the company to report a product complaint with adverse event, concerns an adult caucasian female patient, (b)(6).The medical history included a cerebrovascular accident (cva) in 2006.Concomitant medications: insulin glargine for unknown indication.The patient received human insulin nph (rdna origin) (humulin n) cartridge, 16 iu at night, subcutaneously, for type ii diabetes with complications and glucose control and beginning in (b)(6) 2012.Human insulin nph was delivered via humapen luxura (champagne).In 2014, approximately two years after started human insulin nph treatment, the patient was diagnosed with neuropathy.The corrective treatment and laboratorial exams were not provided and the outcome for neuropathy was not recovered.In (b)(6) 2015, the patient experienced a cerebrovascular accident (cva) with loss of the movement of the left arm and was hospitalized for one week.In the hospital, the patient received an unspecified treatment, the laboratorial exams were not provided and she recovered from cva in (b)(6) 2015.On an unspecified date, after started human insulin nph via humapen luxura champagne (lot 1202b01/(b)(4)), the pen was deregulated, reported as the injection button was not going to the end when pressed and the pen was misaligned with the number zero.In addition, it was reported the patient used the reported device since (b)(6) 2012 and stored the pen on refrigerator.The status of human insulin nph treatment was ongoing.The patient was the user of the device.Training status was not provided.General and suspect device duration of use was not provided.The device was not returned.The consumer reporter did not provide any relatedness opinion.Update 22jan2016: additional information received on 19jan2016 from the global product complaint database updated the device to a humapen luxura (champagne); updated the malfunction field to yes/cirm which updated the device to suspect; added non serious no adverse event to associated to the device; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.Update 29feb2016: additional information received on 29feb2016 from the global product complaint database added the device specific safety summary and manufactured date; added the device is not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.

• Brand Name: HUMAPEN LUXURA CHAMPAGNE
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; medical device manufacturing; 415 red cedar street; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 5409624
• MDR Text Key: 38248246
• Report Number: 1819470-2016-00015
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K142518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9663
• Device Lot Number: 1202B01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 76