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

Model Number MS9698

Device Problem Mechanical Problem (1384)

Patient Problems Chest Pain (1776); Fatigue (1849); Hyperglycemia (1905)

Event Date 07/31/2018

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.This report is associated with 1819470-2018-00156 since there is more than one device implicated.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp) concerned a (b)(6) male patient of unknown origin.Medical history was not provided.Concomitant medications included insulin glargine and tablets reported as diabetenorm, both for unspecified indication.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) via unspecified formulation and human insulin (rdna origin) injections through cartridges, both via reusable devices (humapen ergo ii) and (humapen savvio, graphite) for the treatment of diabetes mellitus (dm).Initially, he received human insulin isophane suspension 70%/ human insulin 30%; dosage regimen, route of administration and start date were not reported.Sometime in (b)(6) 2018, while on human insulin isophane suspension 70%/ human insulin 30% treatment, his blood glucose level reached 500 mg/dl (no reference ranges provided) and he entered the hospital.He also had a stent placement surgery for unspecified condition.He stayed in the hospital for one day.Further hospitalization details including laboratory examination findings and corrective treatment were not provided.In (b)(6) 2018, after he was discharged from hospital, human insulin isophane suspension 70%/ human insulin 30% treatment was stopped.Two weeks after stopping human insulin isophane suspension 70%/ human insulin 30% treatment, still in (b)(6) 2018, he started human insulin (rdna origin) injections (humulin r), 20 iu two times a day and 10 iu at night, subcutaneously, for the treatment of dm.Since an unknown date, while on human insulin therapy, his humapen ergo ii was not working as the injection button was difficult to be pushed down and the external body was damaged (associated product complaint ((b)(4)/ lot number 1010d02).Additionally, the injection button of his humapen savvio, graphite, was difficult to be pushed down (associated (b)(4)/ lot number 1305v06).He did not miss his human insulin dose as he was still using his humapen (unspecified) but he noticed that the human insulin cartridges lasted longer than usual, so he was not sure if he was taking his complete dose or not.On an unknown date while on human insulin therapy, his blood glucose (bg) level reached 300 mg/dl (no reference ranges provided); they returned to 122 mg/dl on (b)(6) 2018.It was thought this happened when he put his humapen (unspecified) in the fridge.As of (b)(6) 2018, reporter provided the information regarding rationale for hospitalization for bg increased and treatment details.He felt tired on this day and he went to the hospital and his gastrologist measured his bg and it was 500 mg/dl.He also mentioned that he had chest pain so he was referred to a cardiologist where he made electrocardiogram (ecg) on his heart and the physician found out his coronary artery of heart was blocked thus going to the surgery room immediately for stent placement.The treatment details included insulin lispro, insulin glargine, plavix, novalib, clopidogrel bisulfate, acetylsalicylic acid, ascorbic acid and atorvastatin calcium.Information regarding further corrective treatment and outcome of the remaining events was not provided.Human insulin therapy was continued; it was unknown whether human insulin isophane suspension 70%/ human insulin 30% therapy would be restarted.The user of the humapens was the patient and his training status was not provided.The humapen ergo ii and humapen savvio models duration of use were not provided; suspect humapens duration of use was not reported.The issues with the humapens were resolved and they were in use.The reporting consumer did not provide an assessment of relatedness between the events and human insulin isophane suspension 70%/ human insulin 30% treatment, human insulin therapy, humapen ergo ii or humapen savvio, graphite.The case was cross referenced with the (b)(4).Update 20-aug-2018: upon review on 20-aug-2018, it was determined that (b)(4) was a duplicate of this report; therefore, (b)(4) will be deleted from the database.All information from (b)(4) has been captured in this report.Edit 22aug2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 22-aug-2018: upon catool reconciliation, added lot number of both devices.Associated pcs were processed.Updated narrative accordingly.Edit 24aug2018: updated medwatch fields for expedited device reporting.No new information added.Edit 24aug2018: updated medwatch fields for expedited device reporting.No new information added.Update 30-aug-2018: additional information received from initial reporter via psp on 27-aug-2018.Added a lab test for ecg, all the treatment medications.Added the serious event of coronary artery blockage.Updated the concomitant medication (insulin glargine) to treatment medication and updated the narrative with new information.

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 dated 25sep2018 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2018-00156 since there is more than one device implicated evaluation summary: a male patient reported the injection button of his humapen savvio device was difficult to push down.The patient he was not sure he was getting his complete dose as the cartridges lasted longer.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1305v06, manufactured may 2013).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.The patient indicated the issue with the device was resolved, and the device was in use.A complaint history review of the batch did not identify any atypical findings with respect to dose accuracy.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.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp) concerned a 53-year-old male patient of unknown origin.Medical history was not provided.Concomitant medications included insulin glargine and tablets reported as diabetenorm, both for unspecified indication.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) via unspecified formulation and human insulin (rdna origin) injections through cartridges, both via a reusable humapen ergo ii and a reusable humapen savvio (graphite) devices for the treatment of diabetes mellitus (dm).Initially, he received human insulin isophane suspension 70%/ human insulin 30%; dosage regimen, route of administration and start date were not reported.Sometime in (b)(6) 2018, while on human insulin isophane suspension 70%/ human insulin 30% treatment, his blood glucose level reached 500 mg/dl (no reference ranges provided) and he entered the hospital.He also had a stent placement surgery for unspecified condition.He stayed in the hospital for one day.Further hospitalization details including laboratory examination findings and corrective treatment were not provided.In (b)(6) 2018, after he was discharged from hospital, human insulin isophane suspension 70%/ human insulin 30% treatment was stopped.Two weeks after stopping human insulin isophane suspension 70%/ human insulin 30% treatment, still in (b)(6) 2018, he started human insulin (rdna origin) injections (humulin r), 20 iu two times a day and 10 iu at night, subcutaneously, for the treatment of dm.Since an unknown date, while on human insulin therapy, his humapen ergo ii was not working as the injection button was difficult to be pushed down and the external body was damaged (associated product complaint (pc: (b)(4)/ lot number 1010d02).Additionally, the injection button of his humapen savvio (graphite) was difficult to be pushed down (associated pc: (b)(4)/ lot number 1305v06).He did not miss his human insulin dose as he was still using his humapen (unspecified) but he noticed that the human insulin cartridges lasted longer than usual, so he was not sure if he was taking his complete dose or not.On an unknown date while on human insulin therapy, his blood glucose (bg) level reached 300 mg/dl (no reference ranges provided); they returned to 122 mg/dl on (b)(6) 2018.It was thought this happened when he put his humapen (unspecified) in the fridge.As of follow up received on (b)(6) 2018, reporter provided the information regarding rationale for hospitalization for bg increased and treatment details.He felt tired on this day and he went to the hospital and his gastrologist measured his bg and it was 500mg/dl.He also mentioned that he had chest pain so he was referred to a cardiologist where he made electrocardiogram (ecg) on his heart and the physician found out his coronary artery of heart was blocked thus going to the surgery room immediately for stent placement.The treatment details included insulin lispro, insulin glargine, plavix, novalib, clopidogrel bisulfate, acetylsalicylic acid, ascorbic acid and atorvastatin calcium.Information regarding further corrective treatment and outcome of the remaining events was not provided.Human insulin therapy was continued; it was unknown whether human insulin isophane suspension 70%/ human insulin 30% therapy would be restarted.The user of the humapen was the patient and his training status was not provided.The humapen ergo ii and humapen savvio models duration of use were not provided; suspect humapen duration of use was not reported.The humapen ergo ii was manufactured in oct2010 and the humapen savvio was manufactured in may2013.The issues with the humapen were resolved and they were in use.The reporting consumer did not provide an assessment of relatedness between the events and human insulin isophane suspension 70%/ human insulin 30% treatment, human insulin therapy, humapen ergo ii or humapen savvio, graphite.The case was cross referenced with the case (b)(4).Update 20-aug-2018: upon review on 20-aug-2018, it was determined that case (b)(4) was a duplicate of this report; therefore, case (b)(4) will be deleted from the database.All information from case (b)(4) has been captured in this report.Edit 22aug2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 22-aug-2018: upon catool reconciliation, added lot number of both devices.Associated pcs were processed.Updated narrative accordingly.Edit 24aug2018: updated medwatch fields for expedited device reporting.No new information added.Edit 24aug2018: updated medwatch fields for expedited device reporting.No new information added.Update 30-aug-2018: additional information received from initial reporter via psp on 27-aug-2018.Added a lab test for ecg, all the treatment medications.Added the serious event of coronary artery blockage.Updated the concomitant medication (insulin glargine) to treatment medication and updated the narrative with new information.Update 25sep2018: additional information received on 25sep2018 from the global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch/european and canadian (eu/ca) device information, improper use and storage from yes to no for pc (b)(4), and device return status to not returned to manufacturer.Added date of manufacturer for pc (b)(4) associated with lot 1305v06 of humapen savvio (graphite).Corresponding fields and narrative updated accordingly.Update 03-oct-2018: no new medically significant information was received from the reporter on 27-sep-2018 in response to requested medical questionnaire.The reported information was already processed in the case.No new relevant information was added to the case.

• Brand Name: HUMAPEN SAVVIO 3ML (GRAPHITE)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 7838782
• MDR Text Key: 119061720
• Report Number: 1819470-2018-00155
• 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: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9698
• Device Lot Number: 1305V06
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR