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

Model Number MS9673

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

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Shock (2072); Diabetic Ketoacidosis (2364)

Event Date 01/31/2017

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

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerns a (b)(6) female patient of an unspecified origin.Medical history included diabetes mellitus type one, hypoglycemia with blood glucose value of 1.8 and hyperglycemia while using insulin aspart and insulin human injection, isophane.Historical drugs included insulin aspart and insulin human injection, isophane, both for the treatment of diabetes mellitus type one.Concomitant medications included insulin glargine for the treatment of diabetes mellitus.The patient received human insulin (rdna origin) injection (humulin r) cartridge three times daily subcutaneously for the treatment of type one diabetes mellitus starting on an unspecified date.Dose was not provided.While using human insulin, approximately during 2003 her blood glucose was abruptly high or low (no units or values were provided); therefore approximately in 2003 she stopped using human insulin and insulin glargine and started using human insulin isophane suspension 70%/ human insulin 30%.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injection (humulin 70/30) cartridge via a reusable pen (humapen luxura half dose) 24iu or 25iu in the morning and 24iu or 25iu in the evening (twice daily) subcutaneously for the treatment of type one diabetes mellitus starting approximately in 2003.On an unspecified date, but while using human insulin isophane suspension 70%/ human insulin 30% the blood glucose was also abruptly high or low with hypoglycemia of 3-4 (no units or reference values provided).During 2017, she experienced ketone bodies caused by insulin, so she was hospitalized for two weeks.Hospitalization dates were not provided.Furthermore, in the evening of (b)(6) 2019, while taking human insulin 70/30 the blood glucose was low at 2.4 (no values or references values provided).On (b)(6) 2019, the blood glucose was high at 17-18 (no values or references values provided).On an unspecified date, while taking human insulin isophane suspension 70%/ human insulin 30% she experienced shock at night, reportedly she had unfixed time shock.After she had shock hypoglycaemic, her family member called ambulance.No further details were provided.The company considered the event of insulin shock as serious due to its medical significance.Furthermore, on an unspecified date, the injection button of the humapen luxura hd was uneasy to push and press, it was uneasy to push and press when did not install the insulin ((b)(4) / lot: 0806g01) and she was hoping to give her injection using the humapen luxura hd as soon as possible.Information regarding corrective treatment was not provided.She recovered from the episodes of blood glucose abruptly high or low while using human insulin.The outcome of the rest of the events was not recovered.Human insulin was discontinued and was not restarted.Since unspecified date, she was changing her dosage regimen of human insulin isophane suspension 70%/ human insulin 30% on her own according to the blood glucose condition.The action taken with human insulin isophane suspension 70%/ human insulin 30% was dose changed.The treatment with human insulin isophane suspension 70%/ human insulin 30% was ongoing.The user of the humapen luxura hd was the patient and her training status was not provided.The general humapen luxura hd model duration of use was not provided.The suspect humapen luxura hd had been used for seven or eight years at the time of initial report and it was started approximately in 2011.The action taken and return status of the suspect humapen luxura hd was not provided.The reporting consumer related the event of blood ketone bodies to the treatment with human insulin isophane suspension 70%/ human insulin 30% and did not relate the remaining events to the treatment of human insulin isophane suspension 70%/ human insulin 30% or human insulin.The reporting consumer did not provide an assessment of relatedness between events and the humapen luxura hd device.Update 25-sep-2019: initial and follow-up both received on 20-sep-2019 were processed at the same time.Update 03-oct-2019: additional information was received from initial reporter via psp on 29-sep-2019.Updated the description as reported and as coded for the event of hypoglycaemic shock.Updated narrative with new information.Edit 08oct2019: updated medwatch fields for expedited device reporting.No new information added.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerns a 39-year-old female patient of an unspecified origin.Medical history included diabetes mellitus type one, hypoglycemia with blood glucose value of 1.8 and hyperglycemia while using insulin aspart and insulin human injection, isophane.Historical drugs included insulin aspart and insulin human injection, isophane, both for the treatment of diabetes mellitus type one.Concomitant medications included insulin glargine for the treatment of diabetes mellitus.The patient received human insulin (rdna origin) injection (humulin r) cartridge three times daily subcutaneously for the treatment of type one diabetes mellitus starting on an unspecified date.Dose was not provided.While using human insulin, approximately during 2003 her blood glucose was abruptly high or low (no units or values were provided); therefore approximately in 2003 she stopped using human insulin and insulin glargine and started using human insulin isophane suspension 70%/ human insulin 30%.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injection (humulin 70/30) cartridge via a reusable pen (humapen luxura half dose) 24iu or 25iu in the morning and 24iu or 25iu in the evening (twice daily) subcutaneously for the treatment of type one diabetes mellitus starting approximately in 2003.On an unspecified date, but while using human insulin isophane suspension 70%/ human insulin 30% the blood glucose was also abruptly high or low with hypoglycemia of 3-4 (no units or reference values provided).During 2017, she experienced ketone bodies caused by insulin, so she was hospitalized for two weeks.Hospitalization dates were not provided.Furthermore, in the evening of (b)(6) 2019, while taking human insulin 70/30 the blood glucose was low at 2.4 (no values or references values provided).On (b)(6) 2019, the blood glucose was high at 17-18 (no values or references values provided).On an unspecified date, while taking human insulin isophane suspension 70%/ human insulin 30% she experienced shock at night, reportedly she had unfixed time shock.After she had shock hypoglycaemic, her family member called ambulance.She was presented with symptoms of discomfort, hands shaking and numbness when hypoglycemia appeared.She ate chocolate and other sweets or sugar when after hypoglycemia appeared and her family member called hospital to give first aid treatment to her at home she was not hospitalized.After emergency treatment, the symptom of shock was recovering but the symptom of hypoglycemia was not recovering.It was reported that because she had type i diabetes mellitus, the doctor did not had a good treatment for her.No further details were provided.The company considered the event of insulin shock as serious due to its medical significance.Furthermore, on an unspecified date, the injection button of the humapen luxura hd was uneasy to push and press, it was uneasy to push and press when did not install the insulin (pc: 4888838/ lot: 0806g01) and she was hoping to give her injection using the humapen luxura hd as soon as possible.Information regarding corrective treatment was not provided.She recovered from the episodes of blood glucose abruptly high or low while using human insulin.The outcome of the rest of the events was not recovered.Human insulin was discontinued and was not restarted.Since unspecified date, she was changing her dosage regimen of human insulin isophane suspension 70%/ human insulin 30% on her own according to the blood glucose condition.The action taken with human insulin isophane suspension 70%/ human insulin 30% was dose changed.The treatment with human insulin isophane suspension 70%/ human insulin 30% was ongoing.The user of the humapen luxura hd was the patient and her training status was not provided.The general humapen luxura hd model duration of use was not provided.The suspect humapen luxura hd had been used for seven or eight years at the time of initial report and it was started approximately in 2011.The suspect device, which was manufactured in jun2008, was returned to the manufacturer on 29sep2019.The reporting consumer related the event of blood ketone bodies to the treatment with human insulin isophane suspension 70%/ human insulin 30% and did not relate the remaining events to the treatment of human insulin isophane suspension 70%/ human insulin 30% or human insulin.The reporting consumer did not provide an assessment of relatedness between events and the humapen luxura hd device.Update 25-sep-2019: initial and follow-up both received on 20-sep-2019 were processed at the same time.Update 03-oct-2019: additional information was received from initial reporter via psp on 29-sep-2019.Updated the description as reported and as coded for the event of hypoglycaemic shock.Updated narrative with new information.Edit 08oct2019: updated medwatch fields for expedited device reporting.No new information added.Update 15-oct-2019: information was received from affiliate via a psp on 11-oct-2019.The patient was inconvenient to answer the phone.No new medically significant information was received and hence no changes were made to the case.Update 22-oct-2019: additional information was received from initial reporter via a psp in response to a follow up questionnaire on 16-oct-2019.Updated: outcome of event shock hypoglycaemic to recovering, and treatment received of events shock hypoglycaemic and hypoglycaemia from unknown to yes.Narrative was updated with new information accordingly.Update 29oct2019: additional information received on 25oct2019 and 28oct2019 from the global product complaint database which were processed together.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, malfunction from unknown to no, and device return status to returned to manufacturer.Added date of manufacturer and date returned to manufacturer for the device associated with (b)(6) with lot 0806g01 of humapen luxura hd device.Corresponding fields and narrative updated accordingly.Edit 18nov2019: the unique device identifier of (b)(4) for the humapen luxura half-dose device was added for expedited device reporting.

Manufacturer Narrative

B.5.Narrative field: new, updated and corrected information is referenced within the update statements in b.5.Please refer to update statement(s) dated 29oct2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that the injection button of her humapen luxura hd device was difficult to press, and the device did not deliver insulin.She experienced hypoglycemic shock.Investigation of the returned device (batch 0806g01, manufactured june 2008) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The investigation also found some visual defects due to field damage not related to the manufacturing process that did not impact the functionality of the device.The patient reported using the device for seven or eight years.The instructions for use states the humapen luxura hd has been designed to be used for up to three years after first use.There is evidence of improper use.The patient used the device beyond its approved use life.This misuse is not likely relevant to the event since the device met functional requirements and met dose accuracy and glide (injection) force specifications.

• 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
• MDR Report Key: 9172552
• MDR Text Key: 173223619
• Report Number: 1819470-2019-00185
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K063151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9673
• Device Lot Number: 0806G01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2019
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 39 YR
• Patient Weight: 59