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

Model Number MS9662

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Hyperglycemia (1905); Hypoglycemia (1912); Unspecified Infection (1930); Necrosis (1971); Loss of Range of Motion (2032); Coma (2417)

Event Type  Injury  

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 via call center to notify an event concerns a male adult patient of unknown origin.Medical history included vision problem corrected by glasses.Concomitant medications were not provided.The patient received human insulin (rdna origin) nph (humulin n) cartridge, 30iu to 40iu, daily, subcutaneously, beginning in 2013, for unknown indication for use.In (b)(6) 2015, approximately two years after commencing human insulin nph treatment via humapen luxura burgundy (batch: 1204b01) the patient suffered an accident.The patient went to a hospital to underwent a surgery to remove a toe.The reporter stated that after the surgery the patient experienced some complications, the patient experienced klebsiella pneumoniae infection.Due the infection the patient experienced leg necrosis and amputee the leg.The reporting consumer also stated that the patient experienced coma for 30 days and whilst in coma the patient blood glucose was 750.Laboratory exams and corrective treatment were not provided.The patient was discharged on an unknown date, as reported as 60 days after the admission date, the reporting consumer stated that the patient was recovering from the necrosis and did not provide the outcome of the blood glucose was 750, coma and the accident.On an unspecified date after the discharge the patient was experiencing difficulties due the prosthesis and was falling a lot.Due the falls the patient lost the movement of one hand.Laboratory exams were not provided.The patient underwent physical therapy as corrective treatment and the patient was recovering from the event.On an undisclosed date, the reporter stated that the patient was experiencing hypoglycemia and stated that the patient diabetes was emotional and due that the patient was having difficulties to handle his blood glucose levels.Laboratory valued and corrective treatment was not provided.The accident, coma, klebsiella pneumoniae infection, leg necrosis, blood glucose was 750, fell and loss of hand movement were considered serious by the company due medically significant reasons.The reporter also stated that the patient was not sure if he was receiving the full dose because when the patient was pressing the injection screw the cursor was going down at once, as reported (product complaint pending/lot 1204b01).Also it was reported that the patient sporadically reuses the needles.Laboratory exams and corrective treatment were not provided.Human insulin nph treatment was continued.Follow up cannot be obtained as the reporter refused further contact.The patient was the device operator and he was properly trained by a physician.He uses the suspect device and the suspect device model for three years.If device is returned, evaluation will be performed.The reporting consumer did not relate the loss of hand movement and leg necrosis to human insulin nph treatment, did not know if the hypoglycemia was related to human insulin nph and did not provide any other relatedness opinion.Update (b)(6) 2016: upon review, the case was opened to update the medwatch fields for regulatory reporting.

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements.Please refer to update statement dated 20may2016.No further follow up is planned.Evaluation summary in (b)(6) 2015, a male patient experienced increased blood glucose and diabetic hyperglycaemic coma.One year later, (b)(6) 2016, the patient reported an event of an incorrect dose being administered.The patient was not sure if he was receiving his full dose from his humapen luxura device.There was no blood sugar event reported with relation to the complaint.The investigation of the returned device (batch 1204b01, manufactured april 2012) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.There is evidence of improper use.The patient reused needles which may be relevant to the complaint of an incorrect dose being administered.

Event Description

(b)(4).This spontaneous case reported by a consumer who contacted the company via call center to notify an event concerns a male adult patient of unknown origin.Medical history included vision problem corrected by glasses.Concomitant medications were not provided.The patient received human insulin (rdna origin) nph (humulin n) cartridge, 30iu to 40iu, daily, subcutaneously, beginning in 2013, for unknown indication for use.In (b)(6) 2015, approximately two years after commencing human insulin nph treatment via humapen luxura burgundy (batch: 1204b01) the patient suffered an accident.The patient went to a hospital to underwent a surgery to remove a toe.The reporter stated that after the surgery the patient experienced some complications, the patient experienced klebsiela pneumonae infection.Due the infection the patient experienced leg necrosis and amputee the leg.The reporting consumer also stated that the patient experienced coma for 30 days and whilst in coma the patient blood glucose was 750.Laboratory exams and corrective treatment were not provided.The patient was discharged on an unknown date, as reported as 60 days after the admission date, the reporting consumer stated that the patient was recovering from the necrosis and did not provide the outcome of the blood glucose was 750, coma and the accident.On an unspecified date after the discharge the patient was experiencing difficulties due the prosthesis and was falling a lot.Due the falls the patient lost the movement of one hand.Laboratory exams were not provided.The patient underwent physical therapy as corrective treatment and the patient was recovering from the event.On an undisclosed date, the reporter stated that the patient was experiencing hypoglycemia and stated that the patient diabetes was emotional and due that the patient was having difficulties to handle his blood glucose levels.Laboratory valued and corrective treatment was not provided.The accident, coma, klebsiela pneumonae infection, leg necrosis, blood glucose was 750, fell and loss of hand movement were considered serious by the company due medically significant reasons.The reporter also stated that the patient was not sure if he was receiving the full dose because when the patient was pressing the injection screw the cursor was going down at once, as reported ((b)(4)/lot 1204b01).Also it was reported that the patient sporadically reuses the needles.Laboratory exams and corrective treatment were not provided.Human insulin nph treatment was continued.Follow up cannot be obtained as the reporter refused further contact.The patient was the device operator and he was properly trained by a physician.He uses the suspect device and the suspect device model for three years.The device was returned on 08apr2016, and no malfunction was found.The reporting consumer did not relate the loss of hand movement and leg necrosis to human insulin nph treatment, did not know if the hypoglycemia was related to human insulin nph and did not provide any other relatedness opinion.Update 09mar2016: upon review, the case was opened to update the medwatch fields for regulatory reporting.Edit 14mar2016: upon review on 14mar2016, the case was opened to add the humapen luxura burgundy device pc number on the case narrative.Narrative updated accordingly.Update 20may2016: additional information received on 19may2016 from the global product complaint database added the device specific safety summary, manufactured date of the device, and return date of the device; updated the malfunction field to no; updated the medwatch and (b)(6) device reporting elements; and updated the narrative.

• Brand Name: HUMAPEN LUXURA BURGUNDY
• 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: 5495175
• MDR Text Key: 40202545
• Report Number: 1819470-2016-00059
• 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: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9662
• Device Lot Number: 1204B01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2016
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 03/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2012
• 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 Outcome(s): Hospitalization; Other
• Patient Weight: 110