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

Model Number MS9694

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problems Emotional Changes (1831); Fall (1848); Hypoglycemia (1912); Loss of consciousness (2418); Confusion/ Disorientation (2553); Weight Changes (2607)

Event Type  Injury  

Manufacturer Narrative

Device not returned.Usage concerns resolved, and device was reported to be working properly.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.

Event Description

(b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerns an adult caucasian female patient of unknown age who was born on (b)(6) 1955.Medical history of the patient included infarction and she suffered three cardiac arrests when she was (b)(6) (reported as in 1997 or 1999, conflicting information).Due to these problems, the patient was hospitalization and underwent three coronary artery bypass graft with saphenous veins and mammary arteries.Also, the patient underwent catheterism.The patient was diagnosed with diabetes during pregnancy and she gained 38 kgs.It was provided the physician did not listen the fetus and she had to remove liquid almost all week (as reported); and endometriosis.Concomitant medications included insulin glargine, atorvastatin calcium, enalapril, atenolol, levothyroxine sodium, acetylsalicylic acid and omeprazole, all of them for unknown indication for use.The patient received insulin lispro (rdna origin) (humalog), cartridge, 8 iu before breakfast, and 6 iu if glycemia value was above 180 or 10 iu if glycemia was above 300 (units were not provided); 10 iu before lunch, and 6 iu if glycemia was below 180 or 12 iu if glycemia was above 300; 10 iu before dinner, and 6 iu if glycemia was below 180 or 12 iu if glycemia was above 300, subcutaneously (only in the abdomen), for type 2 diabetes, starting in 2009 or 2010, reported as after the baby's birth.Insulin lispro was delivered via unspecified devices on an unspecified date.On an unknown date, unknown exact time after starting treatment with insulin lispro, reported as after the birth of patient's daughter, the patient lost 25kgs.No additional information about this event was provided.Information regarding corrective treatment and outcome was not provided.On an unknown date, the patient underwent cataract surgery in the right eye.However, it was provided the patient's recovery was terrible because her eye was hardened and her cornea was injured.The event of cataract was considered serious due to medically significant reasons by the company.The patient did not recover from cataract, hardened eye and injured cornea.On an unknown date, the patient experienced a lot of hypoglycemia.It was provided when the patient experienced hypoglycemia she was disorientated and confused.Also, it was stated when the patient was nervous she experienced hypoglycemia too; it had moments that she was well but suddenly, she blacked out, fell down and went off the air.The event of experienced hypoglycemia and blacked out was considered serious due to medically significant reasons by the company.In addition, in early 2016, approximately six or seven years, after starting insulin lispro treatment, the patient had symptoms of hypoglycemia (unspecified) and she went off the air, but did not faint (as reported).On that day the patient got off a subway station and without knowing it, she took a bus to a place very far away.The patient only went back to normal, when she received help from another person.Also, it was provided the patient did not remember anything about it.Because of that, on an unspecified date, the patient underwent unspecified exams and the result showed the patient had anything and she did not know if this episode occurred due to nervous or stress.Information regarding corrective treatment and outcome from disorientated, confused, went off the air, nervous, blacked out, fell down, did not remember anything and stress was not provided.Furthermore, it was provided the patient did not apply insulin lispro in the arm, because it was very painful.No corrective treatment was provided and the outcome was unknown.On an unspecified date in (b)(6) 2016, the patient started receiving lispro insulin via humapen savvio red.In (b)(6) 2017, humapen savvio (lot number 1406v08) had an issue (product complaint number (b)(4)); also reported as the device was broken; when the patient pressed the injection button, it went down at once, directly and quickly.Because of device problem, the patient was not sure whether received insulin or not and she started injecting insulin via syringe.The outcome from possible drug dose omission was not provided.It was provided the patient had never performed prime of device.As of (b)(6) 2016, it was provided the patient went totally off the air when she experienced hypoglycemia and she was nervous.Because of hypoglycemia the patient has already lost four jobs.The patient lived with his brothers and nephews and when they realized that she experienced hypoglycemia, they put sugar into her cheek and pressed it; however, the outcome from hypoglycemia was not provided.It was also provided the patient was very discouraged and sometimes, she did not feel like doing anything; she did not want to even open her mouth.In addition, it was provided the patient gained weight because she abused the food; she was in a very complicated emotional process (as reported) and when she was at a tense moment, she was more anxious and ended up eating everything.It was stated the patient's height decreased from 160 cm to 159 cm.Information regarding corrective treatment and outcome from very discouraged and did not feel like doing anything, eating disorder, gain weight, anxious and body height decreased was not provided.It was provided the patient has been undergoing blood exam and urinalysis periodically but results were not provided.The insulin lispro therapy was continued.The patient was operator of device and she was a trained user.The patient has used this device model and the reported device since (b)(6) 2016.The complaint was resolved.The device remained in use, and would not be returned.The initial reporter consumer did not know if hypoglycemia was related to emotional problem of the patient; and did not relate he events of went off the air, hypoglycemic unconsciousness, disorientated, confused, nervous, fall, she did not remember anything and stress to insulin lispro therapy.No other opinion of relatedness was provided.Update 19-jul-2016: additional information received on 14-jul-2016 from initial reporting consumer.It was added dose, frequency, indication for use, route of administration and status of lispro insulin; added injection site; added weight and origin of patient; added humapen savvio red as suspect device; added the patient had never performed prime of device; added the patient received insulin lispro via unspecified devices; added pregnancy, diabetes, infarction, hospitalization, cardiac arrest, bypass surgery, catheterism and endometriosis as medical history; added insulin glargine, atorvastatin calcium, enalapril, atenolol, levothyroxine sodium, acetylsalicylic acid and omeprazole as concomitant medications; added blood exam and urinalysis as exams; added non serious adverse events of possible drug dose omission, corneal injury, eye disorder, disorientated, confused, nervous, fall, forgetfulness, stress, dejection emotional, weight gain, weight loss, eating disorder, anxiety and body height decreased; added serious adverse event of cataract; updated as reported of event of hypoglycemia to many hypoglycemia; the patient experienced hypoglycemia and blacked out, recoded it to hypoglycemic unconsciousness and updated to serious; added opinion of relatedness of hypoglycemia on narrative; updated to unknown outcome of the event of patient went off the air; updated as reported causality of the events of went off the air to no.Correspondent fields and narrative were updated accordingly.Update 20jul2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.

Manufacturer Narrative

Narrative field - new, updated and corrected information is referenced within the update statements in describe event or problem.Please refer to update statement dated 12aug2016 in the describe event or problem.No further follow up is planned.Evaluation summary: a female patient reported that her humapen savvio device was "sometimes not releasing insulin." she experienced hypoglycemic unconsciousness.The device was not returned to the manufacturer for investigation (batch (b)(4), manufactured june 2014).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.A complaint history review of this batch did not identify any atypical trends with regard to dose accuracy.Troubleshooting was performed by the patient with guidance of a trained professional, attaching a new needle to the device.The insulin was then released normally.There is evidence of improper use.The patient did not prime the device every time before use.It is unknown if this is relevant to the complaint of hypoglycemic unconsciousness.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerns an adult caucasian female patient of unknown age who was born on (b)(6).Medical history of the patient included infarction and she suffered three cardiac arrests when she was (b)(6) (reported as in 1997 or 1999, conflicting information).Due to these problems, the patient was hospitalization and underwent three coronary artery bypass graft with saphenous veins and mammary arteries.Also, the patient underwent catheterism.The patient was diagnosed with diabetes during pregnancy and she gained 38 kgs.It was provided the physician did not listen the fetus and she had to remove liquid almost all week (as reported); and endometriosis.Concomitant medications included insulin glargine, atorvastatin calcium, enalapril, atenolol, levothyroxine sodium, acetylsalicylic acid and omeprazole, all of them for unknown indication for use.The patient received insulin lispro (rdna origin) (humalog), cartridge, 8 iu before breakfast, and 6 iu if glycemia value was above 180 or 10 iu if glycemia was above 300 (units were not provided); 10 iu before lunch, and 6 iu if glycemia was below 180 or 12 iu if glycemia was above 300; 10 iu before dinner, and 6 iu if glycemia was below 180 or 12 iu if glycemia was above 300, subcutaneously (only in the abdomen), for type 2 diabetes, starting in 2009 or 2010, reported as after the baby's birth.Insulin lispro was delivered via unspecified devices on an unspecified date.On an unknown date, unknown exact time after starting treatment with insulin lispro, reported as after the birth of patient's daughter, the patient lost 25kgs.No additional information about this event was provided.Information regarding corrective treatment and outcome was not provided.On an unknown date, the patient underwent cataract surgery in the right eye.However, it was provided the patient's recovery was terrible because her eye was hardened and her cornea was injured.The event of cataract was considered serious due to medically significant reasons by the company.The patient did not recover from cataract, hardened eye and injured cornea.On an unknown date, the patient experienced a lot of hypoglycemia.It was provided when the patient experienced hypoglycemia she was disorientated and confused.Also, it was stated when the patient was nervous she experienced hypoglycemia too; it had moments that she was well but suddenly, she blacked out, fell down and went off the air.The event of experienced hypoglycemia and blacked out was considered serious due to medically significant reasons by the company.In addition, in early 2016, approximately six or seven years, after starting insulin lispro treatment, the patient had symptoms of hypoglycemia (unspecified) and she went off the air, but did not faint (as reported).On that day the patient got off a subway station and without knowing it, she took a bus to a place very far away.The patient only went back to normal, when she received help from another person.Also, it was provided the patient did not remember anything about it.Because of that, on an unspecified date, the patient underwent unspecified exams and the result showed the patient had anything and she did not know if this episode occurred due to nervous or stress.Information regarding corrective treatment and outcome from disorientated, confused, went off the air, nervous, blacked out, fell down, did not remember anything and stress was not provided.Furthermore, it was provided the patient did not apply insulin lispro in the arm, because it was very painful.No corrective treatment was provided and the outcome was unknown.On an unspecified date in (b)(6) 2016, the patient started receiving lispro insulin via humapen savvio red.In jul2016, humapen savvio (lot number 1406v08) had an issue ((b)(4)); also reported as the device was broken; when the patient pressed the injection button, it went down at once, directly and quickly.Because of device problem, the patient was not sure whether received insulin or not and she started injecting insulin via syringe.The outcome from possible drug dose omission was not provided.It was provided the patient had never performed prime of device.As of (b)(6) 2016, it was provided the patient went totally off the air when she experienced hypoglycemia and she was nervous.Because of hypoglycemia the patient has already lost four jobs.The patient lived with his brothers and nephews and when they realized that she experienced hypoglycemia, they put sugar into her cheek and pressed it; however, the outcome from hypoglycemia was not provided.It was also provided the patient was very discouraged and sometimes, she did not feel like doing anything; she did not want to even open her mouth.In addition, it was provided the patient gained weight because she abused the food; she was in a very complicated emotional process (as reported) and when she was at a tense moment, she was more anxious and ended up eating everything.It was stated the patient's height decreased from 160 cm to 159 cm.Information regarding corrective treatment and outcome from very discouraged and did not feel like doing anything, eating disorder, gain weight, anxious and body height decreased was not provided.It was provided the patient has been undergoing blood exam and urinalysis periodically but results were not provided.The insulin lispro therapy was continued.The patient was operator of device and she was a trained user.The patient has used this device model and the reported device since (b)(6) 2016.The complaint was resolved.The device remained in use, and was not returned.The initial reporter consumer did not know if hypoglycemia was related to emotional problem of the patient; and did not relate he events of went off the air, hypoglycemic unconsciousness, disorientated, confused, nervous, fall, she did not remember anything and stress to insulin lispro therapy.No other opinion of relatedness was provided.Update 19-jul-2016: additional information received on 14-jul-2016 from initial reporting consumer.It was added dose, frequency, indication for use, route of administration and status of lispro insulin; added injection site; added weight and origin of patient; added humapen savvio red as suspect device; added the patient had never performed prime of device; added the patient received insulin lispro via unspecified devices; added pregnancy, diabetes, infarction, hospitalization, cardiac arrest, bypass surgery, catheterism and endometriosis as medical history; added insulin glargine, atorvastatin calcium, enalapril, atenolol, levothyroxine sodium, acetylsalicylic acid and omeprazole as concomitant medications; added blood exam and urinalysis as exams; added non serious adverse events of possible drug dose omission, corneal injury, eye disorder, disorientated, confused, nervous, fall, forgetfulness, stress, dejection emotional, weight gain, weight loss, eating disorder, anxiety and body height decreased; added serious adverse event of cataract; updated as reported of event of hypoglycemia to many hypoglycemia; the patient experienced hypoglycemia and blacked out, recoded it to hypoglycemic unconsciousness and updated to serious; added opinion of relatedness of hypoglycemia on narrative; updated to unknown outcome of the event of patient went off the air; updated as reported causality of the events of went off the air to no.Correspondent fields and narrative were updated accordingly.Update 20jul2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.Update 04aug2016: upon review, this case was opened to correct a future date in the narrative.Update 12aug2016: additional information received on 11aug2016 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 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: 5837306
• MDR Text Key: 51229814
• Report Number: 1819470-2016-00189
• 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: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• 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: 1406V08
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2014
• 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