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

Model Number MS9557

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hyperglycemia (1905); Coma (2417)

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.This report is associated with 1819470-2021-00156 and 1819470-2021-00157 since there is more than one device implicated.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) female patient of unknown ethnicity.Medical history included heart disease, hypertension and diabetes.Concomitant medications included vildaformin and metformin both used for diabetes mellitus.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) through cartridge via a reusable pens (humapen ergo ii), unknown dose twice daily subcutaneously for the treatment of diabetes mellitus beginning on an unknown date.On an unknown date and onset, after starting human insulin isophane suspension 70%/human insulin 30% therapy, she had experienced diabetic comas eight times.She was not hospitalized.No further information provided.The event of diabetic comas considered serious due to medically significant reason.In 2014, she got a humapen ergo ii which got impaired in 2016 ((b)(4), lot 1110d03) and she bought another humapen ergo ii.On an unknown date in (b)(6) 2020, her humapen ergo ii got impaired ((b)(4), lot 0801d02) and used for approximately three and a half years (this was considered as improper use of this device).These humapen ergo ii devices had the same issues as they leaked the insulin.She started to use the syringe and, upon which she started experiencing pain and bruising at site of injection in her abdomen.Since an unknown date, her blood glucose was not stable using syringe and sometimes it got so high to the point that she even could not sleep at night (no values, units and reference range were provided).Since an unknown date, she had fever and was given unspecified pill to treat.On (b)(6) 2021, she started a new humapen ergo ii.By (b)(6) 2021, she had the three impaired humapen ergo devices.On (b)(6) 2021, all the insulin in cartridge was leaked on the floor due to the impairment in the third humapen ergo ii ((b)(4), lot 1709d02).Information regarding corrective treatment for remaining events was not provided.Outcome of the event diabetic coma was recovered, outcome of events blood glucose increased, sleep disorder was not recovered and outcome of remaining events was provided.Status of human insulin isophane suspension 70%/human insulin 30% was continued.The patient was operator of the humapen ergo ii devices and her training status was not provided.The humapen ergo ii model durations of use were not provided.The first suspect humapen ergo ii duration of use with lot number 1110d03 was 2 years (as it was used from 2014 to 2016).The second suspect humapen ergo ii duration of use with lot number 0801d02 was three and a half years (as it was used from 2016 to one and half year from initial report).The third suspect humapen ergo ii duration of use with lot number 1709d02 was 3 days (as it was started on (b)(6) 2021).The action taken with first and second suspect humapen ergo ii devices was discontinued and the status of third humapen ergo ii was not provided however its return status was expected.The reporting consumer did not provide a relatedness assessment between the events and insulin lispro and humapen ergo ii but considered events of injection site pain and bruising as related to use of syringe.Update (b)(6) 2021.Initial information received on (b)(6) 2021 and follow-up information received on 28-oct-2021 was processed together.Update (b)(6) 2021: additional information was received from initial reporting consumer via psp on 07-nov-2021.Added lab test.Added metformin as concomitant medication.Added three non serious events of blood glucose increased, sleep disorder and fever.Updated narrative accordingly to reflect changes.Edit (b)(6) 2021: information received from the initial reporter via psp on 16-nov-2021 and 18-nov-2021 was processed together and related to product complaints only.Upon review of initial information received on 26-oct-2021, added two suspect humapen ergo ii devices and deleted the device with unknown lot number, paired corresponding product complaints.Updated device statement and narrative accordingly with new information.Edit (b)(6) 2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) female patient of unknown ethnicity.Medical history included heart disease, hypertension and diabetes.Concomitant medications included vildaformin and metformin both used for diabetes mellitus.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) through cartridge via a reusable pens (humapen ergo ii), unknown dose twice daily subcutaneously for the treatment of diabetes mellitus beginning on an unknown date.On an unknown date and onset, after starting human insulin isophane suspension 70%/human insulin 30% therapy, she had experienced diabetic comas eight times.She was not hospitalized.No further information provided.The event of diabetic comas considered serious due to medically significant reason.In 2014, she got a humapen ergo ii which got impaired in 2016 ((b)(4), lot 1110d03) and she bought another humapen ergo ii.On an unknown date in (b)(6) 2020, her humapen ergo ii got impaired ((b)(4), lot 0801d02) and used for approximately three and a half years (this was considered as improper use of this device).These humapen ergo ii devices had the same issues as they leaked the insulin.She started to use the syringe and, upon which she started experiencing pain and bruising at site of injection in her abdomen.Since an unknown date, her blood glucose was not stable using syringe and sometimes it got so high to the point that she even could not sleep at night (no values, units and reference range were provided).Since an unknown date, she had fever and was given unspecified pill to treat.On (b)(6) 2021, she started a new humapen ergo ii.By (b)(6) 2021, she had the three impaired humapen ergo devices.On (b)(6) 2021, all the insulin in cartridge was leaked on the floor due to the impairment in the third humapen ergo ii ((b)(4), lot 1709d02).Information regarding corrective treatment for remaining events was not provided.Outcome of the event diabetic coma was recovered, outcome of events blood glucose increased, sleep disorder was not recovered and outcome of remaining events was provided.Status of human insulin isophane suspension 70%/human insulin 30% was continued.The patient was operator of the humapen ergo ii devices and her training status was not provided.The humapen ergo ii model durations of use were not provided.The first suspect humapen ergo ii duration of use with lot number 1110d03 was 2 years (as it was used from 2014 to 2016).The second suspect humapen ergo ii duration of use with lot number 0801d02 was three and a half years (as it was used from 2016 to one and half year from initial report).The third suspect humapen ergo ii duration of use with lot number 1709d02 was 3 days (as it was started on (b)(6) 2021).The action taken with first and second suspect humapen ergo ii devices was discontinued and the status of third humapen ergo ii was not provided however its return status was expected.The reporting consumer did not provide a relatedness assessment between the events and insulin lispro and humapen ergo ii but considered events of injection site pain and bruising as related to use of syringe.Update (b)(6) 2021.Initial information received on (b)(6) 2021 and follow-up information received on 28-oct-2021 was processed together.Update (b)(6) 2021: additional information was received from initial reporting consumer via psp on 07-nov-2021.Added lab test.Added metformin as concomitant medication.Added three non serious events of blood glucose increased, sleep disorder and fever.Updated narrative accordingly to reflect changes.Edit (b)(6) 2021: information received from the initial reporter via psp on 16-nov-2021 and 18-nov-2021 was processed together and related to product complaints only.Upon review of initial information received on 26-oct-2021, added two suspect humapen ergo ii devices and deleted the device with unknown lot number, paired corresponding product complaints.Updated device statement and narrative accordingly with new information.Edit (b)(6) 2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

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.This report is associated with 1819470-2021-00156 and 1819470-2021-00157 since there is more than one device implicated.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 54-year-old female patient of unknown ethnicity.Medical history included heart disease, hypertension and diabetes.Concomitant medications included vildaformin and metformin both used for diabetes mellitus.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) through cartridge via a reusable pens (humapen ergo ii), unknown dose twice daily subcutaneously for the treatment of diabetes mellitus beginning on an unknown date.In 2014, she got a humapen ergo ii which got impaired in 2016 (pc (b)(4), lot 1110d03) and she bought another humapen ergo ii (lot 0801d02).On an unknown date and onset, after starting human insulin isophane suspension 70%/human insulin 30% therapy via humapen ergo ii (lot 1110d03 and lot 0801d02), she had experienced diabetic comas eight times.She was not hospitalized.No further information provided.The event of diabetic comas considered serious due to medically significant reason.On an unknown date in apr-2020, her humapen ergo ii got impaired (pc 5767541, lot 0801d02) and used for approximately three and a half years (this was considered as improper use of this device).These humapen ergo ii devices had the same issues as they leaked the insulin.She started to use the syringe and, upon which she started experiencing pain and bruising at site of injection in her abdomen.Since an unknown date, her blood glucose was not stable using syringe and sometimes it got so high to the point that she even could not sleep at night (no values, units and reference range were provided).Since an unknown date, she had fever and was given unspecified pill to treat.On (b)(6) 2021, she started a new humapen ergo ii.Information regarding corrective treatment for remaining events was not provided.Outcome of the event diabetic coma was recovered, outcome of events blood glucose increased, sleep disorder, injection site pain were not recovered and outcome of remaining events was provided.Status of human insulin isophane suspension 70%/human insulin 30% was continued.The patient was operator of the humapen ergo ii devices and her training status was not provided.The humapen ergo ii model durations of use were not provided.The first suspect humapen ergo ii duration of use with lot number 1110d03 was 2 years (as it was used from 2014 to 2016).The second suspect humapen ergo ii duration of use with lot number 0801d02 was three and a half years (as it was used from 2016).The action taken with first and second suspect humapen ergo ii devices was discontinued and were not returned to manufacturer.The reporting consumer did not provide a relatedness assessment between the events and insulin lispro and humapen ergo ii but considered events of injection site pain and bruising as related to use of syringe.Update 01-nov-2021.Initial information received on 26-oct-2021 and follow-up information received on 28-oct-2021 was processed together.Update 11-nov-2021: additional information was received from initial reporting consumer via psp on 07-nov-2021.Added lab test.Added metformin as concomitant medication.Added three non serious events of blood glucose increased, sleep disorder and fever.Updated narrative accordingly to reflect changes.Edit 23-nov-2021: information received from the initial reporter via psp on 16-nov-2021 and 18-nov-2021 was processed together and related to product complaints only.Upon review of initial information received on 26-oct-2021, added two suspect humapen ergo ii devices and deleted the device with unknown lot number, paired corresponding product complaints.Updated device statement and narrative accordingly with new information.Edit 24nov2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 02-dec-2021: additional information was received from initial reporting consumer via psp 30-nov-2021.Updated outcome of the event injection site pain from unknown to not recovered.Updated narrative with new information.Edit 20-dec-2021: upon information received on 30nov2021 from global complaint department, updated the causality from device nhcp to not associated on the humapen ergo ii (lot 1709d02) and also made the device concomitant.Updated narrative accordingly.Update 20-dec-2021: additional information received on 14-dec-2021 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields, added date of manufacture for the suspect humapen ergo ii device associated with pc 5767532 and pc 5767541.Corresponding fields and narrative updated accordingly.Update 23-dec-2021: additional information received on 30-nov-2021 from initial consumer reporter regarding that device with pc (b)(4) was not associated to the event of diabetic comas.No changes were made in this case as already done in this case.

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(s) dated 20dec2021 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2021-00156 since there is more than one device implicated.Evaluation summary a female patient reported that when using a humapen ergo ii device, "all the insulin in cartridge was leaked on the floor." she further reported that the device leaked the insulin before she injected herself, when the humapen ergo ii was in a vertical position it didn't leak, but when she moved the pen to the injection position the pen leaked the insulin.The patient experienced diabetic coma.The device was not returned to the manufacturer for investigation (batch 1110d03, manufactured october 2011).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review did not identify any atypical findings with regard to the leaking issue described by the patient, and a batch complaint threshold review did not identify any atypical findings with regard to the dose accuracy issues.There is no evidence of improper use or storage.

• 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): TECH GROUP NORTH AMERICA INC. DBA WEST; 640 south rockford drive; tempe AZ 85281
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 12870514
• MDR Text Key: 285939250
• Report Number: 1819470-2021-00169
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• 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: 1110D03
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2011
• 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
• Patient Age: 54 YR
• Patient Sex: Female