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

Model Number MS9557

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hyperglycemia (1905); Unspecified Infection (1930); Sepsis (2067); No Code Available (3191)

Event Date 10/31/2016

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

Lilly case id:(b)(4).This report is associated with product compliant:(b)(4).This solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter, concerned a (b)(6) (conflicting information also reported as (b)(6)) male patient of unknown ethnicity.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) (humalog mix25) 15 iu daily, for treatment of diabetes, since (b)(6) 2010 (conflicting information also reported as 2011 and 2012) from cartridge via reusable pen (humapen ergo ii).Route of administration was not reported.In (b)(6) 2016 to (b)(6) 2016, while on insulin lispro 75/25, he got bad and entered emergency on (b)(6) 2016 and was hospitalized for 15 days.Then he was transferred to another hospital and he remained there for 10-15 days (did not remember the time exactly) due to an infection in right foot.Then, he was at his home.In (b)(6) 2016, he was admitted again due to problems of his sugar, problem in foot since the diabetes and the diabetic foot (which he had had it for a long time) got complicated.He presented a septicemia due to a generalized infection.The event septicemia was considered serious due to other medically significant.On an unknown date, sometime while taking insulin lispro protamine suspension 75%/ insulin lispro 25%, he experienced kidney problems and diabetic foot, so he was hospitalized on (b)(6) 2016.No more details regarding hospitalization were provided.On (b)(6) 2016, it was possible that the insulin lispro protamine suspension 75%/ insulin lispro 25% did not enter into his body and returned to the cartridge due to the humapen ergo ii did not work (lot 1205d01; pc 3854795).On that same day, the glucose levels rose (normal measurements: 103 to 108 mg/dl); he had 200 mg/dl in the morning.Just as precaution, he received 10 iu and also at night.By (b)(6) 2016 in the morning, he woke up with 237 mg/dl.In (b)(6) 2017, he was bad and was taken to a clinic in order to be stabilized and he was sent to intensive care.Due to a catheterization performed on (b)(6) 2017, he presented an infection that spread out to the right foot.He was transferred to the other hospital to be performed other tests with the physician from the cardiovascular area to be performed an intervention or operation to the veins, however it did not cause him any benefit in his veins problems.On (b)(6) 2017, he was taken to this clinic again due to a very strong infection and he was in intensive care.In (b)(6) 2017 he was performed an intervention in his right foot.He was receiving beneperen antibiotic (as reported) for his foot infection.Wrong dose administered and blood glucose increased (first episode) events were reported as ongoing.Information regarding corrective treatment and outcome of the remaining events was not provided.Insulin lispro protamine suspension 75%/ insulin lispro 25% treatment status was restarted in (b)(6) 2017 and was continued.The operator of the device was the patient and his training status was unknown.The general device and the reported device duration of use were not provided.The action taken and the status of the device were unknown.The reporting consumer did not provide an assessment of relatedness between the events and insulin lispro protamine suspension 75%/ insulin lispro 25% and the device.Update 19-dec-2016: additional information received on 06-nov-2016 from the initial reporter via psp.Added non serious events of wrong dose administered and blood glucose increased.Added blood glucose lab data, recoded insulin lispro protamine suspension 75%/ insulin lispro 25% unknown formulation to cartridge, added dosage slide with lot number, dosage regimen, indication for use and conflicting start date.Updated patients age, insulin lispro protamine suspension 75%/ insulin lispro 25% treatment status and action taken status from unknown to dose increased.Narrative and fields were updated accordingly.Update 21-dec-2016: additional information received on 20-dec-2016 from the affiliate.The product complaints were provided and processed accordingly.It was entered a new suspect device according to the information provided in the product complaint.Narrative was updated with new information.Update 09-nov-2017: additional information received on 06-nov-2017 from the initial reporter via psp.Added serious events of diabetic foot infection, blood sugar increased, septicemia and non serious event of vein disorder, added new dosing regimen with lot number, lab and updated narrative with new information.Update 04dec2017: updated medwatch fields for expedited device reporting.No new information added.Edit 04dec2017: upon review of the information, the eu/ca fields for the humapen ergo ii were updated.No other changes done.

Event Description

(b)(4) this solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter, concerned a (b)(6)-year-old (conflicting information also reported as (b)(6)-year-old) male patient of unknown ethnicity.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) (humalog mix25) 15 iu daily, for treatment of diabetes, since (b)(6)-2010 (conflicting information also reported as 2011 and 2012) from cartridge via reusable pen (humapen ergo ii).Route of administration was not reported.In (b)(6)-2016 to (b)(6)-2016, while on insulin lispro 75/25 he got bad and entered emergency on (b)(6) 2016 and was hospitalized for 15 days.Then he was transferred to another hospital and he remained there for 10-15 days (did not remember the time exactly) due to an infection in right foot.Then, he was at his home.In (b)(6)-2016, he was admitted again due to problems of his sugar, problem in foot since the diabetes and the diabetic foot (which he had had it for a long time) got complicated.He presented a septicemia due to a generalized infection.The event septicemia was considered serious due to other medically significant.On an unknown date, sometime while taking insulin lispro protamine suspension 75%/ insulin lispro 25%, he experienced kidney problems and diabetic foot, so he was hospitalized on (b)(6)-2016.No more details regarding hospitalization were provided.On (b)(6)-2016, it was possible that the insulin lispro protamine suspension 75%/ insulin lispro 25% did not enter into his body and returned to the cartridge due to the humapen ergo ii did not work.It was further noted that the injection button went down too fast and the insulin went back into the cartridge (lot 1205d01; (b)(4)).In addition, it was reported that the patient only primed the device when using a new cartridge.On that same day, the glucose levels rose (normal measurements: 103 to 108 mg/dl); he had 200 mg/dl in the morning.Just as precaution, he received 10 iu and also at night.By (b)(6)-2016 in the morning, he woke up with 237 mg/dl.In (b)(6)-2017, he was bad and was taken to a clinic in order to be stabilized and he was sent to intensive care.Due to a catheterization performed on (b)(6)-2017, he presented an infection that spread out to the right foot.He was transferred to the other hospital to be performed other tests with the physician from the cardiovascular area to be performed an intervention or operation to the veins, however it did not cause him any benefit in his veins problems.On (b)(6)-2017, he was taken to this clinic again due to a very strong infection and he was in intensive care.In (b)(6)-2017, he was performed an intervention in his right foot.He was receiving beneperen antibiotic (as reported) for her foot infection.Wrong dose administered and blood glucose increased (first episode) events were reported as ongoing.Information regarding corrective treatment and outcome of the remaining events was not provided.Insulin lispro protamine suspension 75%/ insulin lispro 25% treatment status was restarted in (b)(6)-2017 and was continued.The operator of the device was the patient and his training status was unknown.The general device duration of use was not provided.The suspect device duration of use was approximately four years.The suspect device with (b)(4), which was manufactured in may2012, was not returned to the manufacturer.The reporting consumer did not provide an assessment of relatedness between the events and insulin lispro protamine suspension 75%/ insulin lispro 25% and the device.Update 19-dec-2016: additional information received on 15-dec-2016 from the initial reporter via psp.Added non serious events of wrong dose administered and blood glucose increased.Added blood glucose lab data, recoded insulin lispro protamine suspension 75%/ insulin lispro 25% unknown formulation to cartridge, added dosage slide with lot number, dosage regimen, indication for use and conflicting start date.Updated patients age, insulin lispro protamine suspension 75%/ insulin lispro 25% treatment status and action taken status from unknown to dose increased.Narrative and fields were updated accordingly.Update 21-dec-2016: additional information received on 20-dec-2016 from the affiliate.The product complaints were provided and processed accordingly.It was entered a new suspect device according to the information provided in the product complaint.Narrative was updated with new information.Update 09-nov-2017: additional information received on 06-nov-2017 from the initial reporter via psp.Added serious events of diabetic foot infection, blood sugar increased, septicemia and non serious event of vein disorder, added new dosing regimen with lot number, lab and updated narrative with new information.Update 04dec2017: updated medwatch fields for expedited device reporting.No new information added.Edit 04dec2017: upon review of the information, the eu/(b)(6) fields for the humapen ergo ii were updated.No other changes done.Update 09jan2018: additional information received on 08jan2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and (b)(6) device information, improper use and storage from no to yes, and device return status to not returned to manufacturer.Added date of manufacturer for (b)(4) associated with lot 1205d01 of a humapen ergo ii device.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

Narrative field: new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 09jan2018.No further follow-up is planned.Evaluation summary: a wife of a male patient reported the patient's humapen ergo ii device was not working correctly, that the injection button goes down too fast and the insulin goes back into the cartridge.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch number 1205d01, manufactured may 2012).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 findings with regard to the complaint device not working or dose accuracy.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 only primed the device when using a new cartridge.The core user manual instructs the patient to prime the device using 2 units before every injection until insulin is seen at the needle tip.In addition, the patient had used the device for four years.The core user manual states the humapen ergo ii device has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient did not prime the device before each injection.This may be relevant to the event of increased blood glucose.The patient also used the device beyond its approved use life, although it is unknown if this is relevant to the event.

• 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 Key: 7083511
• MDR Text Key: 93753716
• Report Number: 1819470-2017-00205
• 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: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 1205D01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR