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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9557
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problems Fatigue (1849); Hyperglycemia (1905); Complete Heart Block (2627)
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 1819470-2018-00155 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 27-aug-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 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 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.
 
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 1819470-2018-00155 since there is more than one device implicated.Evaluation summary : a male patient reported the injection button of his humapen ergo ii device was difficult to push down, and the external body was damaged.The patient was not sure he was getting his complete dose as the cartridges were lasting longer.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1010d02, manufactured october 2010).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.All humapen ergo ii 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 the batch did not identify any atypical findings with respect to device broken or dose accuracy issues.While the duration of use was not provided, it is likely the device was used beyond its approved use life given the time elapsed since the device was manufactured (october 2010).The core instructions for use state the device was designed to be used for up to 3 years after first use.There is evidence of improper use.The patient used the device beyond its approved use life.This is likely not relevant to the complaints of device broken or dose accuracy.
 
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 jul-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 jul-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 jul-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 follow up received on 27-aug-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 (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.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 (b)(4).And device return status to not returned to manufacturer.Added date of manufacturer for (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.
 
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Brand Name
HUMAPEN ERGO II
Type of Device
FOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
MDR Report Key7839730
MDR Text Key119030160
Report Number1819470-2018-00156
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K151686
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMS9557
Device Lot Number1010D02
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/05/2018
Initial Date FDA Received08/31/2018
Supplement Dates Manufacturer Received09/25/2018
Supplement Dates FDA Received10/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age53 YR
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