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

Model Number MS9663

Device Problems Break (1069); Improper Flow or Infusion (2954); Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

Complaint suggestive of reportable malfunction/incident.Will investigate further.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, regarding a patient who took part of a patient support program (psp), concerns a caucasian male patient born on (b)(6).Medical history: blind, also reported as vision loss, with only notion of clarity in one of the eyes.Concomitant medication: insulin glargine for unknown indication.The patient received insulin lispro (humalog) cartridge, 2iu at breakfast, 3iu at lunch, 2iu at dinner and for all meals if glycemic level is above 250mg/dl it is added 1iu to the normal dose, at maximum five times a day, subcutaneously (in the thigh and arm), for type 2 diabetes, beginning approximately in 2011.On a non-reported date, during treatment with insulin lispro via humapen luxura champagne, the device was jammed and its case was broken.Troubleshooting was performed with a new needle and selected dose of 2iu, twice, and the medication was released normally, however it was reported that the numbers in the dose window and the dose indicator were not aligned ((b)(4)/lot 0907b03).It was stated that sometimes when the dose of 2iu was selected, only a drop or two were released.It was stated by the reporter that the patient preferred to keep his glycaemia high than take the risk of presenting low glycaemia, which had already happened, and feel unwell.The event of low glycaemia led the patient to inject an inferior dose than what was prescribed and also occurred due to forgetting to inject the dose.The patient received another injection of insulin to treat the event of high glycaemia; no corrective treatment was received for the event of low glycemia.No information of laboratorial exams was provided.The patient was recovered from the events of high and low glycaemia.The needles were sporadically reused, the priming of the device was never done and the patient who was blind did the injections.The treatment with insulin lispro was continued.The patient and his wife were the operators of the device, however the patient was the operator for most of the time, and they were trained by a company representative.It was unknown how long the device model and the reported device had been used but it was reported to be over two years.It was unknown if the use of humapen luxura champagne was continued.The device was expected to return.Complaint suggestive of reportable malfunction/incident.Will investigate further.The reporting consumer related the event of low glycaemia to the use of insulin lispro and no relatedness opinion was provided for the remaining events.Update 09may2016: additional information received from call center on 04may2016 was processed within the initial case.

Manufacturer Narrative

No further follow up is planned.Evaluation summary: the wife of a male patient reported that her husband's humapen luxura device was jamming sometimes.The patient support center was able to guide the user in troubleshooting the device with a new needle and selected dose of 2 iu, twice, and the medication was released normally.It was reported that the numbers in the dose window and the dose indicator were not aligned and sometimes only drops came out when she selected 2 iu.The patient experienced non-serious increases and decreases in blood glucose levels.The device was not returned to the manufacturer for investigation (batch 0907b03, manufactured july 2009).The narrative may suggest the presence of a known malfunction (barrel misalignment).Since the device was not returned, a 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 or pen jams.All humapen luxura devices are assessed for dose number alignment during and at the end of the manufacturing process, which also ensures barrel alignment.The reported stated that her husband is blind and is the primary user of the device.The patient reuses needles/ does not prime the device.The instructions for use instruct the user to use a new needle and to prime before each injection.In addition, the user manual states that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it.The user manual also states if any of the parts of your humapen luxura appear broken or damaged, do not use.There is evidence of improper use.The patient reused needles/did not prime the device, which may be relevant to the complaint and the non-serious event of increased blood glucose levels but is unlikely relevant to the complaint of decreased blood glucose levels.In addition, the patient used the device while visually impaired.This may be relevant to the complaint and the blood glucose issues.

Event Description

(b)(4).This report is associated with product compliant: (b)(4).This solicited case reported by a consumer, regarding a patient who took part of a patient support program (psp), concerns an adult caucasian male patient who was born on (b)(6) 1964.The medical history included: blind, also reported as vision loss, with only notion of clarity in one of the eyes.Concomitant medication included insulin glargine for unknown indication.The patient received insulin lispro (humalog) cartridge, 2 iu at breakfast, 3 iu at lunch, 2 iu at dinner and for all meals if glycemic level is above 250 mg/dl it is added 1 iu to the normal dose, at maximum five times a day, subcutaneously (in the thigh and arm), for type 2 diabetes, beginning approximately in 2011.On a non-reported date, during treatment with insulin lispro via humapen luxura champagne, the device was jammed and its case was broken.Troubleshooting was performed with a new needle and selected dose of 2 iu, twice, and the medication was released normally, however it was reported that the numbers in the dose window and the dose indicator were not aligned (product complaint (b)(4) / lot number 0907b03).It was stated that sometimes when the dose of 2 iu was selected, only a drop or two were released.It was stated by the reporter that the patient preferred to keep his glycaemia high than take the risk of presenting low glycaemia, which had already happened, and he felt unwell.The event of low glycaemia led the patient to inject an inferior dose than what was prescribed and the event of glycaemia high also occurred due to patient forgetting to inject the dose.The patient received another injection of insulin to treat the event of high glycaemia; no corrective treatment was received for the event of low glycemia.No information of exams was provided.The patient was recovered from the events of high and low glycaemia.The needles were sporadically reused, the priming of the device was never done and the patient who was blind did the injections.Due to the fact that the patient was blind, he could not always check the medication ejection and the possibility of the device not working properly worried him.It was also stated that due to the patient being visually handicapped, the device jammed (lot number 0907b03) and the selected dose of insulin lispro was not wholly injected and there was always medication left.Information regarding corrective treatment and outcome of underdose event was not provided.The treatment with insulin lispro was continued.The patient and his wife were the operators of the device, however the patient was the operator for most of the time, and they were trained by a company representative.It was unknown how long the device model and the reported device had been used but it was reported to be over two years.The device was not returned.The reporting consumer related the event of low glycaemia to the use of insulin lispro and no relatedness opinion was provided for the remaining events.This case is cross-referenced to cases (b)(4).Update 09may2016: additional information received from call center on 04may2016 was processed within the initial case.Edit 13may2016: upon internal review on 12may2016 for regulatory submission, it was corrected the consequence of the event drug dose omission.Edit 10jun2016: upon internal review on 10jun2016, it was added to the narrative that due to the patient being blind and he could not visually check the medication ejection, the possibility of the device not working properly worried the patient.Update 13jun2016: additional information was received on 07jun2016 from initial reporting consumer via psp and from call center on 10jun2016.Added the non-serious event of underdose and cross-referenced cases (b)(4).Narrative and corresponding fields were updated accordingly.Update 20jun2016: additional information received on 20jun2016 from the global product complaint database added the device specific safety summary and manufactured date of the device; added the device was 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: 5653855
• MDR Text Key: 46260526
• Report Number: 1819470-2016-00121
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9663
• Device Lot Number: 0907B03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2009
• 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: 70