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

Model Number MS9557

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 01/31/2013

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

(b)(4).This solicited case reported by a consumer via patient support program (psp), with additional information from the original reporter via a psp, concerned an (b)(6) asian male patient.Medical history and concomitant medications were unknown.The patient received human insulin (rdna) injections (humulin) via cartridge through reusable pen (humapen ergo ii) subcutaneously, for the treatment of diabetes mellitus beginning in 2012 and discontinued one or two months later because it was not available in his hospital, dosage regimen was not provided.After discontinuing human insulin he received insulin lispro (rdna) injections (humalog) via cartridge through reusable pen (humapen ergo ii) 42 (no units) daily, subcutaneously, for the treatment of diabetes mellitus, beginning in 2012.On an unspecified date in 2013 or 2014, his eyes could not see clearly.Additionally in 2013 while he was using insulin lispro he experienced blood glucose increased and due to this he was hospitalized for two weeks.Dates of hospitalization or further details were not provided.Additionally, he experienced blood glucose increased, due to this the dosage of insulin lispro increased to 18 each morning, 20 each noon and 18 each evening (no units).Additionally on an unspecified date he could not inject enough dosage of insulin lispro because his humapen ergo ii had a failure (lot 1110d01 product complaint unknown), due to this his blood glucose increased, it was 10-11 (no units) before breakfast, 12-13 (no units) before dinner and also 15-16 (no units) before dinner.His current weight was (b)(6), he was thin than before.Information regarding corrective treatment and outcome of was unknown.Human insulin was discontinued on an unspecified date in 2012, insulin lispro was continued.The user of the device was the patient and his training status was not provided.The device model and suspect device duration of use was about four years beginning in 2012.The action taken with the suspect device was not provided and its return was not expected.The reporting consumer did not know if the events were related to the human insulin or the insulin lispro.For the humapen ergo ii, he did not provide an assessment of relatedness.Update 12-aug-2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.Update 19-aug-2016: additional information received form the initial reporter via a psp on 17-aug-2016.Added onset date for the event of eyes could not see clearly.Updated narrative with new information.

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 12sep2016 in describe event or problem.No further follow up is planned.Evaluation summary a consumer reported on behalf of a male patient that the injection force of his humapen ergo ii device was high and air had entered the cartridge.He was unable to inject enough insulin and experienced non-serious increased blood glucose levels.The device was not returned to the manufacturer for investigation (batch (b)(4), manufactured october 2011).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of this batch did not identify any atypical trends with regard to dose accuracy or injection force high.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.The patient stated that he is not changing the needle for each injection and stored the device with the needle attached.This is consistent with the reported presence of air bubbles in the cartridge.The user manual instructs to use a new needle for each injection and to not store the pen with a needle attached.The patient also reported that "his eyes could not see clearly." the user manual states that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it.There is evidence of improper use.The user reused needles.This may be relevant to the non-serious event of increased blood glucose levels.In addition, the patient used the device while visually impaired.This may be relevant to the event of underdose.

Event Description

(b)(4).This solicited case reported by a consumer via a patient support program (psp), with additional information from the original reporter via a psp, concerned an (b)(6) male patient.Medical history and concomitant medications were unknown.The patient received human insulin (rdna) injections (humulin) from a cartridge through reusable pen (humapen ergo ii), subcutaneously for the treatment of diabetes mellitus, beginning in 2012 and discontinued one or two months later because it was not available in his hospital, dosage regimen was not provided.After discontinuing human insulin, he received insulin lispro (rdna) injections (humalog 100 u/ml) from a cartridge through reusable pen (humapen ergo ii), 42 unspecified units once daily subcutaneously for the treatment of diabetes mellitus, beginning in 2012.On an unspecified date in 2013 or 2014, his eyes could not see clearly.Additionally in 2013, while he was using insulin lispro he experienced blood glucose increased and due to this he was hospitalized for two weeks.The cause of the increased glucose that resulted in hospitalization was diabetes.Dates of hospitalization or further details were not provided.Additionally, he experienced blood glucose increased, due to this the dosage of insulin lispro increased to 18 each morning, 20 each noon and 18 each evening (unspecified units reported).Additionally on an unspecified date, he could not inject enough dosage of insulin lispro because his humapen ergo ii had a failure (lot 1110d01 (b)(4)), due to this his blood glucose increased, it was 10-11 (no units) before breakfast, 12-13 (no units) before dinner and also 15-16 (no units) before dinner.His current weight was 51 kg, he was thin than before.On an unknown date, he had cataract and glaucoma after used human insulin and insulin lispro.The cataract and glaucoma were the cause of the visual loss.The events of cataract, glaucoma and visual loss were considered serious due to medical significance.His visual acuity prior to start human insulin and insulin lispro was not tested but currently visual acuity was 0.4 (no units or reference ranges were provided) in right eye and 0.5 (no units or reference ranges were provided) in left eye.His father had cataract too.He considered it was scleroderma which caused weight loss.Information regarding corrective treatments and outcome of the events was not provided.Human insulin was discontinued on an unspecified date in 2012 but insulin lispro was continued.The user of the device was the patient and his training status was not provided.The device model and suspect device duration of use was about four years beginning in 2012.The device was not returned.The reporting consumer did not know if the events of vision abnormal, blood glucose increased, weight decreased and underdose were related to the human insulin or the insulin lispro but did not provide a relatedness assessment between the remaining events and the drugs.For the humapen ergo ii, he did not provide an assessment of relatedness.Update 12-aug-2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.Update 19-aug-2016: additional information received from the initial reporter via a psp on 17-aug-2016.Added onset date for the event of eyes could not see clearly.Updated narrative with new information.Update 26-aug-2016: additional information was received from the initial reporter via a psp on 23-aug-2016.Added laboratory tests, three new serious events of cataract, glaucoma and vision lost and a new non-serious event of scleroderma.Updated the event of blood glucose increased to possible worsening of diabetes and narrative with new information.Update 12sep2016: additional information received on 09sep2016 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.Update 12-sep-2016: information from internal communications received on 11-aug-2016.(b)(4) was received but it was already processed.Narrative was updated with new information.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 5906428
• MDR Text Key: 53438159
• Report Number: 1819470-2016-00216
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• 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: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 1110D01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2016
• 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): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 51