MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN; FOR TREATMENT PURPOSES

Model Number MS9673

Device Problems Fluid/Blood Leak (1250); High Readings (2459); Low Readings (2460)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Skin Irritation (2076)

Event Date 10/26/2017

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 solicited case, reported by a consumer who was contacted by the company via patient support program (psp), concerns a male patient with age and ethnicity unknown, (b)(6).Medical history: diagnosed with type 1 diabetes in 2011.Concomitant medication was not provided.The patient received human insulin (rdna origin) nph (humulin n), cartridge, via reusable pen and insulin lispro (rdna origin) via kwikpen, both at unspecified dose, frequency reported as many times, route of administration, for type 1 diabetes, beginning on an unknown date.On an unknown date, unknown time after beginning insulin lispro and human insulin nph therapy, while receiving human insulin nph via humapen luxura half dose (hd) pen (lot 1009g01), when the needle of 8 mm was used for application, patient experienced some little lumps, but after the needles were changed from 8 mm to 4 mm, the lumps did not appear more.It was reported that each needle was used four times.Further, it was provide that sometimes bled after the application, but it was not often and sometimes a little bit of insulin came out of the skin even waiting 10 seconds and this happened more with insulin lispro.It was reported that sometimes patients glycaemia was very high and sometimes it was very low, but it was more common to be high.On (b)(6) 2017 patients glycaemia reached 549 (no units and normal ranges were provided), which was considered serious due to medically significant reasons by the company, and as corrective treatment for that insulin lispro was applied in a higher dose and then patient recovered from the event as his glycaemia went back to normal.No other information about exams, corrective treatment and outcome was provided.On (b)(6) 2017 human insulin nph and insulin lispro were ongoing.The patients mother operated the devices and it was unknown if she was trained.The patient had used the reported humapen luxura half dose pen (lot 1009g01) for five years and kwikpen for unknown time and both devices models for unknown time.Return status of both devices was unknown.The consumer reporter did not provide a relatedness opinion.Edit 07nov2017: upon internal review it was filled the field of number of years since manufacturing date.Update 15nov2017: updated medwatch fields for expedited device reporting.Upon review, added the unique device identifier (udi) number for the suspect humapen luxura hd.No new information added.

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements.Please refer to update statement dated 28nov2017.No further follow-up is planned.Evaluation summary: the patient's mother reported sometimes, insulin leaked from the injection site after the patient received his dose from his humapen luxura hd device.The patient's mother also reported sometimes, the patient bled from the injection site after receiving his dose.The patient experienced increased blood glucose.The device was not returned for investigation (batch number 1009g01, manufactured september 2010).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen luxura hd devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.The mother of the patient indicated the patient had used the humapen luxura hd device for 5 years.The user manual states the humapen luxura hd device has been designed to be used for up to 3 years after first use.The patient's mother also reported that each needle was used four times.The instructions for use state, "use a new needle for each injection; remove the needle after every use; and do not store the pen with the needle attached." there is evidence of improper use.The patient reused needles and used the device beyond its approved use life.Needle reuse maybe relevant to the event of increased blood glucose.Using the device beyond the recommended use life may not be relevant to the event of increased blood glucose.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer who was contacted by the company via patient support program (psp), concerns a male patient with age and ethnicity unknown, born on (b)(6) 2001.Medical history: diagnosed with type 1 diabetes in 2011.Concomitant medication was not provided.The patient received human insulin (rdna origin) nph (humulin n), cartridge, via reusable luxura half-dose pen and insulin lispro (rdna origin) via kwikpen, both at unspecified dose, frequency reported as many times, route of administration, for type 1 diabetes, beginning on an unknown date.On an unknown date, unknown time after beginning insulin lispro and human insulin nph therapy, while receiving human insulin nph via humapen luxura half dose (hd) pen (lot 1009g01), when the needle of 8mm was used for application, patient experienced some little lumps, but after the needles were changed from 8mm to 4mm, the lumps did not appear more.It was reported that each needle was used four times.Further, it was provide that sometimes he bled after the application, but it was not often.In addition, sometimes a little bit of insulin came out of the skin, even waiting 10 seconds, and this happened more with insulin lispro via kwikpen than with human insulin via luxura half-dose pen (product complaint (b)(4), lot number c475082c and product complaint (b)(4), lot number 1009g01).It was reported that sometimes patients glycaemia was very high and sometimes it was very low, but it was more common to be high.On (b)(6) 2017 patients glycaemia reached 549 (no units and normal ranges were provided), which was considered serious due to medically significant reasons by the company, and as corrective treatment for that insulin lispro was applied in a higher dose and then patient recovered from the event as his glycaemia went back to normal.No other information about exams, corrective treatment and outcome was provided.On (b)(6) 2017 human insulin nph and insulin lispro were ongoing.The mother of the patient operated the devices and it was unknown if she was trained.The patient had used the suspect humapen luxura half dose pen for five years and kwikpen for unknown time and the general use of both devices models for unknown time.The suspect humapen luxura half-dose device associated with product complaint (b)(4) was not returned to the manufacturer; information on the return status of the kwikpen was not provided.The consumer reporter did not provide any relatedness opinion.Edit 07nov2017: upon internal review it was filled the field of number of years since manufacturing date.Update 15nov2017: updated medwatch fields for expedited device reporting.Upon review, added the unique device identifier (udi) number for the suspect humapen luxura hd.No new information added.Update 28nov2017: additional information received on 27nov2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated humapen luxura half-dose device, model ms9673a to humapen luxura half-dose, with model ms9673; along with the medwatch fields with device information and the european and (b)(6) (eu/(b)(6)) device information.Added date of manufacturer for the humapen luxura half-dose device associated with product complaint (b)(4), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN LUXURA HALF-DOSE PEN
• 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: 7049482
• MDR Text Key: 92686352
• Report Number: 1819470-2017-00203
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• Combination Product (y/n): N
• PMA/PMN Number: K063151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

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: MS9673
• Device Lot Number: 1009G01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 11/27/2017
• Supplement Dates FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2010
• 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): Other
• Patient Age: 16 YR