MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (RED); FOR TREATMENT PURPOSES

Model Number MS9694

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

Patient Problems Fainting (1847); Hyperglycemia (1905); Hypoglycemia (1912); Incontinence (1928); Nausea (1970); Loss of Vision (2139); Vomiting (2144)

Event Date 07/01/2016

Event Type  Injury  

Manufacturer Narrative

There was no reported complaint for this device and its return is not expected.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 a patient support program (psp), concerns a female patient of unknown origin born on (b)(6).Medical history: ovary and bowel cancers; malaise, vomiting and blood glucose fluctuation.Concomitant medication: unspecified chemotherapy started in 2008 for ovary and intestine cancers and human insulin nph (another manufacturer) for unknown indication.The patient received insulin lispro (humalog) cartridge, unknown dose and frequency, subcutaneously, for unknown indication, beginning on (b)(6) 2016.On a non-reported date, unclear if before or after starting treatment with insulin lispro, patient lost the vision.No further information was provided regarding this event.It was unknown if any corrective measure was taken and the outcome was not provided.The event of vision loss was considered serious due to disability.On an unspecified date in (b)(6) 2016 at dawn, unknown time after starting treatment with insulin lispro via humapen savvio red (lot number c348039a), patient started to feel unwell, had nausea and vomiting, was urinating and defecating on clothes, speaking words that did not make any sense, and her blood glucose was oscillating.Also, it was reported that patient fainted and had to be taken to hospital, unclear if hospitalized or not.The event of fainting was considered serious due to medically significant reason by the company.According to reporter, it happened two times after starting insulin lispro therapy.In these occasions patient glycaemia reached 30, 35 (unit and normal range not provided) however her glycaemia was oscillating a lot, decreased and increased suddenly.Thus, due to that, patient had to receive glucose in her vein as corrective treatment.The event of blood glucose fluctuation was considered serious by the company due to intervention required criteria.No other information regarding corrective treatment for the remaining events was provided.As of (b)(6) 2016, the patient had not recovered from malaise.On (b)(6) 2016 the insulin lispro therapy was discontinued by the treating physician, and the patient would return to her endocrinologist in 25 days to verify if insulin lispro therapy would be restarted or not.As of (b)(6) 2016, the patient was bedridden, but her glucose was starting to be under control, she was feeding and her nausea stopped but it was unknown if the vomiting stopped too.The outcome for remaining events was not provided.The patient and the reporter were the operators of the humapen savvio red and it was unknown if they were trained.It was unknown how long humapen savvio model and the reported device had been used.It was unknown if the use of humapen savvio red was continued.The device was not expected to return.The reporting consumer did not relate the events of blood glucose fluctuation, malaise and vomiting to the use of insulin lispro; however it was stated that the vomiting might have been related to the chemotherapy treatment.No other relatedness assessment was provided.Update 27jul2016: additional information received on 22jul2016 from initial reporting consumer.Added malaise, vomiting and blood glucose fluctuation as medical history; added that concomitant human insulin nph was from another manufacturer; updated start date of insulin lispro therapy; added nausea, disorganized speech, urinary and fecal incontinence as non-serious adverse events; added fainting as serious adverse event; added blood glucose values as laboratorial examination; updated the status of insulin lispro therapy; updated outcome for blood glucose fluctuation and vomiting and added outcome for nausea; updated narrative and corresponding fields accordingly.Edit 29jul2016.Case was opened to enter the medwatch device fields for device mailing.No new information.

Manufacturer Narrative

No further follow up is planned.Evaluation summary: there was evidence of improper use of the device.It was reported the patient used the device while she was blind.There was no product complaint relative to pen function, however, the use error may be relevant to the event of blood glucose fluctuation.The device user manual indicates that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it.

Event Description

(b)(4).This solicited case reported by a consumer, who was contacted by the company via a patient support program (psp), concerns a female patient of unknown origin born on (b)(6) 1948.Medical history: ovary and bowel cancers; malaise, vomiting and blood glucose fluctuation.Concomitant medication: unspecified chemotherapy started in 2008 for ovary and intestine cancers and human insulin nph (another manufacturer) for unknown indication.The patient received insulin lispro (humalog) cartridge, unknown dose and frequency, subcutaneously, for unknown indication, beginning on (b)(6) 2016.On a non-reported date, unclear if before or after starting treatment with insulin lispro, patient lost the vision.No further information was provided regarding this event.It was unknown if any corrective measure was taken and the outcome was not provided.The event of vision loss was considered serious due to disability.On an unspecified date in (b)(6) 2016 at dawn, unknown time after starting treatment with insulin lispro via humapen savvio red (lot number c348039a), patient started to feel unwell, had nausea and vomiting, was urinating and defecating on clothes, speaking words that did not make any sense, and her blood glucose was oscillating.Also, it was reported that patient fainted and had to be taken to hospital, unclear if hospitalized or not.The event of fainting was considered serious due to medically significant reason by the company.According to reporter, it happened two times after starting insulin lispro therapy.In these occasions patient glycaemia reached 30, 35 (unit and normal range not provided) however her glycaemia was oscillating a lot, decreased and increased suddenly.Thus, due to that, patient had to receive glucose in her vein as corrective treatment.The event of blood glucose fluctuation was considered serious by the company due to intervention required criteria.No other information regarding corrective treatment for the remaining events was provided.As of (b)(6) 2016, the patient had not recovered from malaise.On (b)(6) 2016 the insulin lispro therapy was discontinued by the treating physician, and the patient would return to her endocrinologist in 25 days to verify if insulin lispro therapy would be restarted or not.As of (b)(6) 2016, the patient was bedridden, but her glucose was starting to be under control, she was feeding and her nausea stopped but it was unknown if the vomiting stopped too.The outcome for remaining events was not provided.The patient and the reporter were the operators of the humapen savvio red and it was unknown if they were trained.It was unknown how long humapen savvio model and the reported device had been used.It was unknown if the use of humapen savvio red was continued.The device was not returned.The reporting consumer did not relate the events of blood glucose fluctuation, malaise and vomiting to the use of insulin lispro; however it was stated that the vomiting might have been related to the chemotherapy treatment.No other relatedness assessment was provided.Update 27jul2016: additional information received on 22jul2016 from initial reporting consumer.Added malaise, vomiting and blood glucose fluctuation as medical history; added that concomitant human insulin nph was from another manufacturer; updated start date of insulin lispro therapy; added nausea, disorganized speech, urinary and fecal incontinence as non-serious adverse events; added fainting as serious adverse event; added blood glucose values as laboratorial examination; updated the status of insulin lispro therapy; updated outcome for blood glucose fluctuation and vomiting and added outcome for nausea; updated narrative and corresponding fields accordingly.Edit 29jul2016.Case was opened to enter the medwatch device fields for device mailing.No new information.Update 05aug2016: upon review of the information from 14jul2016, this case was opened to update the improper use and storage to yes for device use with vision impairment.Update 09aug2016: additional information received on 09aug2016 from the global product complaint database added the device specific safety summary; added the device was not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.

• Brand Name: HUMAPEN SAVVIO 3ML (RED)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 5849757
• MDR Text Key: 51258306
• Report Number: 1819470-2016-00190
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K160668
• 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: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9694
• Device Lot Number: C348039A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 68 YR