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

Model Number MS9663

Device Problems Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339); Mechanical Jam (2983)

Patient Problems Fatigue (1849); Hyperglycemia (1905); Pain (1994); Swelling (2091); Depression (2361); Coma (2417); Weight Changes (2607)

Event Date 06/30/2015

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 an adverse event and a product complaint, with additional information provided by another consumer, concerns a (b)(6) male patient.Medical history: high blood pressure, high cholesterol and cataract surgery.The concomitant medications included sitagliptin phosphate, amlodipine besilato + hydrochlorothiazide + valsartan, atenolol, acetylsalicylic acid, atorvastatin calcium, tamsulosin hydrochloride, colecalciferol, ginkgo biloba, metformin for unknown indication.The patient received human insulin nph (humulin n), cartridge 30iu each morning, 20iu at afternoon and 20iu before dinner, subcutaneously, for diabetes, beginning before 1998.On unknown date, since beginning of treatment with human insulin nph via humapen luxura champagne, the patient experienced paralysis of kidney and they were working just 30%.In 2013, the patient had a cerebrovascular accident (cva) which led the left his left side of body disable and with a labyrinth disorder.The events of kidney paralysis, cva and left side of body disable were considered serious due to medically significant reason by the company.The patient did not receive corrective treatment neither recovered from kidney paralysis, cva, left side of body disable and labyrinth disorder.In (b)(6) 2015, the patient experienced uncontrolled glycemia, described as high blood glucose of 500mg/dl and entered a coma.Due to that, the patient was hospitalized during four days.As corrective treatment, the patient started in (b)(6) 2015, treatment with human insulin regular (humulin r) cartridge, 8iu each morning, 6iu at lunch and 4iu before dinner, subcutaneously, for diabetes.On (b)(6) 2016, his humapen luxura champagne (lot 0803b02 and (b)(4)) did not deliver insulin because it jammed and sometimes it delivered too much insulin for once, thus, the patient started another humapen, unknown device.On unspecified date, during treatment with human insulin nph and human insulin regular via humapen luxura champagne and humapen, unknown device, the patient experienced swelling, tiredness, beginning of depression, gained a lot of weight, spot in his belly after injection, bleeding from injection site and pain when applied cold insulin.The patient did not receive corrective treatment neither recovered from swelling, tiredness, beginning of depression, weight gain, spot in his belly after injection, bleeding from injection site and pain during injection.The patient stored both in use insulins and devices in refrigerator and reused the needles (bd brand) for three times.Treatment with human insulin nph and human insulin regular was continued.The daughter of patient operated the device and she was a trained user.It was unknown how long the patient had used the reported devices and these devices model.Return of humapen luxura champagne was expected and if device is returned evaluation will be performed to determine if a malfunction has occurred.Return of humapen, unknown device was not expected once there was no product complaint associated with this device.The first reporting consumer related the high glycemia with coma to human insulin nph, and swelling, and beginning of depression to both human insulin nph and human insulin regular, however, related the tiredness to age of patient.The second reporting consumer related weight gain, spots on belly, bleeding after injection and pain during injection to human insulin nph and human insulin regular.No other opinion of relatedness was provided.(b)(4).Update -12may2016: additional information received on 10may2016 from a second reporting consumer was processed with initial case entry.Edit -13may2016.Case was opened to enter medwatch device fields for device mailing.No new information.Noted improper use update -16may2016.Additional information received 11may2016 from the product complaint safety database did not contain any new information.Edit -19may2016: upon internal review correct information that humapen luxura champagne (lot 0803b02) did not deliver insulin.

Manufacturer Narrative

No further follow up is planned.Evaluation summary a male patient reported that his humapen luxura device was jammed but sometimes would produce a jet of insulin.The patient experienced increased blood glucose levels and hyperglycemia.The device was not returned for investigation (batch 0803b02, manufactured march 2008).Therefore, the device could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of for the batch did not identify any atypical trends with regard to dose accuracy.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy.The device user manual instructs to use a new needle for each injection and not to store the device in a refrigerator.There is evidence of improper use.The patient reuses needles and stored the device in the refrigerator.Needle reuse may be relevant to the complaint of pen jamming and increased blood glucose levels and hyperglycemia.

Event Description

(b)(4).This spontaneous case, reported by a consumer, who contacted the company to report an adverse event and a product complaint, with additional information provided by another consumer, concerns an (b)(6) caucasian male patient.Medical history: high blood pressure, high cholesterol and cataract surgery.The concomitant medications included sitagliptin phosphate, amlodipine besilato + hydrochlorothiazide + valsartan, atenolol, acetylsalicylic acid, atorvastatin calcium, tamsulosin hydrochloride, colecalciferol, ginkgo biloba, metformin for unknown indication.The patient received human insulin nph (humulin n), cartridge 30iu each morning, 20iu at afternoon and 20iu before dinner, subcutaneously, for diabetes, beginning before 1998.On unknown date, since beginning of treatment with human insulin nph via humapen luxura champagne, the patient experienced paralysis of kidney and they were working just 30%.In 2013, the patient had a cerebrovascular accident (cva) which led the left his left side of body disable and with a labyrinth disorder.The events of kidney paralysis, cva and left side of body disable were considered serious due to medically significant reason by the company.The patient did not receive corrective treatment neither recovered from kidney paralysis, cva, left side of body disable and labyrinth disorder.In (b)(6) 2015, the patient experienced uncontrolled glycemia, described as high blood glucose of 500mg/dl and entered a coma.Due to that, the patient was hospitalized during four days.As corrective treatment the patient started in (b)(6) 2015, treatment with human insulin regular (humulin r) cartridge, 8iu each morning, 6iu at lunch and 4iu before dinner, subcutaneously, for diabetes.On (b)(6) 2016, his humapen luxura champagne (lot 0803b02 and pc (b)(4)) did not deliver insulin because it jammed and sometimes it delivered too much insulin for once, thus, the patient started another humapen, unknown device.On unspecified date, during treatment with human insulin nph and human insulin regular via humapen luxura champagne and humapen, unknown device, the patient experienced swelling, tiredness, beginning of depression, gained a lot of weight, spot in his belly after injection, bleeding from injection site and pain when applied cold insulin.The patient did not receive corrective treatment neither recovered from swelling, tiredness, beginning of depression, weight gain, spot in his belly after injection, bleeding from injection site and pain during injection.The patient stored both in use insulins and devices in refrigerator and reused the needles (bd brand) for three times.Treatment with human insulin nph and human insulin regular was continued.The daughter of patient operated the device and she was a trained user.It was unknown how long the patient had used the reported devices and these devices model.Return of humapen luxura champagne was expected and if device is returned evaluation will be performed to determine if a malfunction has occurred.The device was not returned.The first reporting consumer related the high glycemia with coma to human insulin nph, and swelling, and beginning of depression to both human insulin nph and human insulin regular, however, related the tiredness to age of patient.The second reporting consumer related weight gain, spots on belly, bleeding after injection and pain during injection to human insulin nph and human insulin regular.No other opinion of relatedness was provided.This case is cross referenced to (b)(4).Update 12may2016: additional information received on 10may2016 from a second reporting consumer was processed with initial case entry.Edit 13may2016.Case was opened to enter medwatch device fields for device mailing.No new information.Noted improper use update 16may2016.Additional information received 11may2016 from the product complaint safety database did not contain any new information.Edit 19may2016: upon internal review correct information that humapen luxura champagne (lot 0803b02) did not deliver insulin.Update 24may2016: additional information received on 23may2016 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 narrative.Update 02jun2016: upon review, the case was opened to place the complete device specific safety summary in the analysis summary for reporting form.

Manufacturer Narrative

Narrative field - new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 24aug2018.No further follow up is planned.Evaluation summary: a male patient reported that his humapen luxura device was jammed but sometimes would produce a jet of insulin.The patient experienced increased blood glucose levels and hyperglycemia.Investigation of the returned device (batch 0803b02, manufactured march 2008) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The patient also reported that he stored both in use insulins and devices in refrigerator and reused the needles (bd brand) for three times.The device user manual instructs to use a new needle for each injection and not to store the device in a refrigerator.There is evidence of improper use.The patient reuses needles and stored the device in the refrigerator.Needle reuse may be relevant to the complaint of pen jamming and increased blood glucose levels and hyperglycemia.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer, who contacted the company to report an adverse event and a product complaint (pc), with additional information provided by initial reporter and another consumer, concerns an 82-year-old caucasian male patient.Medical history: high blood pressure, high cholesterol and cataract surgery.The concomitant medications included sitagliptin phosphate, amlodipine besilato + hydrochlorothiazide + valsartan, atenolol, acetylsalicylic acid, atorvastatin calcium, tamsulosin hydrochloride, colecalciferol, ginkgo biloba, metformin for unknown indications.The patient received human insulin nph (humulin n), cartridge 30iu each morning, 20iu at afternoon and 20iu before dinner, subcutaneously, for diabetes, beginning before 1998 (also reported as more than 25 years).On unknown date, since beginning of treatment with human insulin nph via humapen luxura champagne, the patient experienced paralysis of kidney and they were working just 30%.In 2013, the patient had a cerebrovascular accident (cva) which led the left his left side of body disable and with a labyrinth disorder.The events of kidney paralysis, cva and left side of body disable were considered serious due to medically significant reason by the company.The patient did not receive corrective treatment neither recovered from kidney paralysis, cva, left side of body disable and labyrinth disorder.In (b)(6) 2015, the patient experienced uncontrolled glycemia, described as high blood glucose of 500mg/dl and entered a coma.Due to that, the patient was hospitalized during four days.As corrective treatment the patient started in (b)(6) 2015, treatment with human insulin regular (humulin r) cartridge, 8iu each morning, 6iu at lunch and 4iu before dinner, subcutaneously, for diabetes.On (b)(6) 2016, his humapen luxura champagne (lot 0803b02 and pc 3655328) did not deliver insulin because it jammed and sometimes it delivered too much insulin for once, thus, the patient started another humapen, unknown device.On unspecified date, during treatment with human insulin nph and human insulin regular via humapen luxura champagne and humapen, unknown device, the patient experienced swelling, tiredness, beginning of depression, gained a lot of weight, spot in his belly after injection, bleeding from injection site and pain when applied cold insulin.The patient did not receive corrective treatment neither recovered from swelling, tiredness, beginning of depression, weight gain, spot in his belly after injection, bleeding from injection site and pain during injection.The patient stored both in use insulins and devices in refrigerator and reused the needles (bd brand) for three times.As per the follow up received on 10apr2018, since unspecified date, the patient blood glucose was very high (results not provided) and, according to reporter, human regular insulin and human insulin nph was not solving it.Due to that, on (b)(6) 2018, the patient started to use insulin glargine.Furthermore, human insulin nph was discontinued and the human insulin regular was used only if patient blood glucose reached 201 (units not provided).According to reporter, the insulin regular dosage would depend on patient blood glucose and the patient physician did a table to help him with these doses.No further information was provided.The daughter of patient operated the device and she was a trained user.It was unknown how long the patient had used the reported devices and these devices model.The suspect device with pc 3655328, which was manufactured in mar2008, was returned to the manufacturer on 13jun2016.The first reporting consumer related the high glycemia with coma to human insulin nph, and swelling and beginning of depression to both human insulin nph and human insulin regular, however, related the tiredness to age of patient.The second reporting consumer related weight gain, spots on belly, bleeding after injection, pain during injection and blood glucose was very high to human insulin nph and human insulin regular.No other opinion of relatedness was provided.This case is cross referenced to (b)(4) and (b)(4) (same reporter); (b)(4) (same patient).Update 12may2016: additional information received on 10may2016 from a second reporting consumer was processed with initial case entry.Edit 13may2016.Case was opened to enter medwatch device fields for device mailing.No new information.Noted improper use.Update 16may2016.Additional information received 11may2016 from the product complaint safety database did not contain any new information.Edit 19may2016: upon internal review correct information that humapen luxura champagne (lot 0803b02) did not deliver insulin.Update 24may2016: additional information received on 23may2016 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 narrative.Update 02jun2016: upon review, the case was opened to place the complete device specific safety summary in the analysis summary for reporting form.Update 13apr2018: additional information received on 10apr2018 and 11apr2018 from the both reporting consumers.Removed the information that human insulin nph was ongoing.Added the non-serious events of patient blood glucose was very high.Narrative and corresponding fields were updated accordingly.Edit 16apr2018: upon internal review, a non-medically significant edit was completed in order to updated human insulin nph action taken from no change to drug discontinued; added an unknown dose (as needed) for human insulin regular that was ongoing; removed ongoing from the others human insulin regular doses; added cross-referenced cases.Edit 16apr2018: reopened the case to include edit statement (16apr2018).Update 27aug2018: additional information received on 24aug2018 from the global product complaint database.Entered updated device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information, malfunction from unknown to no, and device return status to returned to manufacturer.Updated date of manufacturer and added date returned to manufacturer for pc 3655328 associated with lot 0803b02 of a humapen luxura (champagne) device.Corresponding fields and narrative updated accordingly.Edit 30aug2018: upon internal review, device return date was updated from 13jun2018 to 13jun2016 and updated the lss reporting form from 24may2016 to 27aug2018.Edit 18sep2018: upon internal review, added the mdfr codes for expedited device reporting.

• Brand Name: HUMAPEN LUXURA CHAMPAGNE
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 5670149
• MDR Text Key: 45647622
• Report Number: 1819470-2016-00127
• 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,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• 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: 0803B02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Date Manufacturer Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AAS; ATENOLOL; ATORVASTATINA; DEPURA; EXFORGE HCT; GINKGO BILOBA; GLIFAGE; HUMULIN N; HUMULIN R; HYDROCHLORATHIAZIDE, VALSARTAN; JANUVIA; SECOTEX
• Patient Outcome(s): Hospitalization
• Patient Age: 82 YR
• Patient Weight: 80