MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO, TEAL/CLEAR/CLEAR CH; FOR TREATMENT PURPOSES

Model Number MS8929

Device Problem Insufficient Information (3190)

Patient Problems Hypoglycemia (1912); Seizures (2063); Depression (2361)

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 to report a product complaint, with additional information from a second consumer, concerns a (b)(6) male patient of unknown origin.The medical history of patient included emotionally unbalanced (as reported).The concomitant medication was not provided.The patient received insulin lispro (humalog) cartridge, unknown dose, frequency, route of administration and indication for use, beginning approximately in 2006.On an unknown date the patient started to use humapen ergo teal/clear in order to deliver insulin lispro.On an unspecified date, unknown time after the starting of insulin lispro via reusable pen, the patient experienced depression due to unknown cause and he was experiencing convulsions due to hypoglycemia (no value was provided) even he was eating and counting carbohydrates correctly.Information regarding exams, corrective treatment and outcome of the events was not provided.The events of hypoglycemia and hypoglycemic convulsions were considered serious by the company due to medically significant reasons.According to first reporting consumer the humapen ergo teal/clear (lot number 0404a03/(b)(4)) started to present problems due to its excessive use.The second reporting consumer stated that the little rubber where the thumb leaned was dilated (as reported) and due to that the dose knob did not turn completely and a maneuver was performed in order to apply insulin successfully.Treatment with insulin lispro was continued.No follow-up will be attempted as the reporting consumer declined to allow contact by the company.The patient operated the device but it was unknown if he was trained.It was unknown how long the patient had used the device model and the reported device.The device return was expected.If device is returned, evaluation will be performed to determine if a malfunction has occurred.The first and second reporting consumers did not provide any relatedness opinion.Update 28apr2016: upon review, the case was opened to add the (b)(4) to the narrative, and added the medwatch field for regulatory reporting.

Manufacturer Narrative

No further follow up is planned.Evaluation summary: a male patient reported that when using his humapen ergo device that the "rubber which supports the thumb finger has dilated, and when he will apply insulin, this dilated rubber jams and the dose knob does not turn until the end." in addition, the patient reported that "a maneuver was performed in order to apply insulin successfully." he experienced hypoglycemia.The device was not returned to the manufacturer for investigation (batch 0404a03, manufactured april 2004).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.While the exact nature of the patient's problem with the device is unclear, a complaint history review of the batch did not identify any atypical trends with regard to dose accuracy or device not working.While the exact date the patient started using the device could not be determined, it is likely the patient used the device beyond its approved use life based on the amount of time elapsed since it was manufactured (2004).The user manual states the humapen ergo has been designed to be used for up to 3 years after first use.The user manual also states if any of the parts of your humapen ergo appear broken or damaged, do not use.There is evidence of improper use.The patient likely used the device beyond the approved use life and used the device after experiencing problems with the injection button.It is unclear if is this is relevant to the complaint of hypoglycemia.

Event Description

Lilly case id: (b)(6).This spontaneous case, reported by a consumer who contacted the company to report a product complaint, with additional information from a second consumer, concerns a (b)(6) male patient of unknown origin.The medical history of patient included emotionally unbalanced (as reported).The concomitant medication was not provided.The patient received insulin lispro (humalog) cartridge, unknown dose, frequency, route of administration and indication for use, beginning approximately in 2006.On an unknown date the patient started to use humapen ergo teal/clear in order to deliver insulin lispro.On an unspecified date, unknown time after the starting of insulin lispro via reusable pen, the patient experienced depression due to unknown cause and he was experiencing convulsions due to hypoglycemia (no value was provided) even he was eating and counting carbohydrates correctly.Information regarding exams, corrective treatment and outcome of the events was not provided.The events of hypoglycemia and hypoglycemic convulsions were considered serious by the company due to medically significant reasons.According to first reporting consumer the humapen ergo teal/clear (lot number 0404a03/product complaint (b)(4)) started to present problems due to its excessive use.The second reporting consumer stated that the little rubber where the thumb leaned was dilated (as reported) and due to that the dose knob did not turn completely and a maneuver was performed in order to apply insulin successfully.Treatment with insulin lispro was continued.No follow-up will be attempted as the reporting consumer declined to allow contact by the company.The patient operated the device but it was unknown if he was trained.It was unknown how long the patient had used the device model and the reported device.The device was not returned.The first and second reporting consumers did not provide any relatedness opinion.Update 28apr2016: upon review, the case was opened to add the product complaint number (b)(4) to the narrative, and added the medwatch field for regulatory reporting.Update 01jun2016: additional information received on 31may2016 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 improper use and storage to yes; updated the medwatch and european and (b)(4) required device reporting elements; and updated the narrative.

Manufacturer Narrative

No further follow up is planned.Evaluation summary: a male patient reported that when using his humapen ergo device that the "rubber which supports the thumb finger has dilated, and when he will apply insulin, this dilated rubber jams and the dose knob does not turn until the end." in addition, the patient reported that "a maneuver was performed in order to apply insulin successfully." he experienced hypoglycemia.Investigation of the returned device (batch 0404a03, manufactured april 2004) found that the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.Note that the soft touch (an external feature on the device body designed to enhance the grip of the user) was found to be peeling due to damage while in the field by abrasive forces or chemicals.While the exact date the patient started using the device could not be determined, it is likely the patient used the device beyond its approved use life based on the amount of time elapsed since it was manufactured (2004).The user manual states the humapen ergo has been designed to be used for up to 3 years after first use.The user manual also states if any of the parts of your humapen ergo appear broken or damaged, do not use.There is evidence of improper use.The patient likely used the device beyond the approved use life and used the device after experiencing problems with the injection button.The soft touch was also damaged while in the field.These issues may not be relevant to the complaint of hypoglycemia as the device met functional requirements and met dose accuracy and glide (injection) force specifications.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report a product complaint, with additional information from a second consumer, concerns a (b)(6) male patient of unknown origin.The medical history of patient included emotionally unbalanced (as reported).The concomitant medication was not provided.The patient received insulin lispro (humalog) cartridge, unknown dose, frequency, route of administration and indication for use, beginning approximately in 2006.On an unknown date the patient started to use humapen ergo teal/clear in order to deliver insulin lispro.On an unspecified date, unknown time after the starting of insulin lispro via reusable pen, the patient experienced depression due to unknown cause and he was experiencing convulsions due to hypoglycemia (no value was provided) even he was eating and counting carbohydrates correctly.Information regarding exams, corrective treatment and outcome of the events was not provided.The events of hypoglycemia and hypoglycemic convulsions were considered serious by the company due to medically significant reasons.According to first reporting consumer the humapen ergo teal/clear (lot number 0404a03/product complaint (b)(4)) started to present problems due to its excessive use.The second reporting consumer stated that the little rubber where the thumb leaned was dilated (as reported) and due to that the dose knob did not turn completely and a maneuver was performed in order to apply insulin successfully.Treatment with insulin lispro was continued.No follow-up will be attempted as the reporting consumer declined to allow contact by the company.The patient operated the device but it was unknown if he was trained.It was unknown how long the patient had used the device model and the reported device.The device was returned 02jun2016, and no malfunction was found.The first and second reporting consumers did not provide any relatedness opinion.Update 28apr2016: upon review, the case was opened to add the product complaint number (b)(4) to the narrative, and added the medwatch field for regulatory reporting.Update 01jun2016: additional information received on 31may2016 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 improper use and storage to yes; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.Update 01aug2016: additional information received on 29jul2016 from the global product complaint database added the device specific safety summary and return date of the device; updated the malfunction to no; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.

• Brand Name: HUMAPEN ERGO, TEAL/CLEAR/CLEAR CH
• 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; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 5644253
• MDR Text Key: 44893098
• Report Number: 1819470-2016-00111
• Device Sequence Number: 1
• Product Code: NSC
• Combination Product (y/n): N
• PMA/PMN Number: K982842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS8929
• Device Lot Number: 0404A03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 41 YR