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

Model Number UNKNOWN

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Inflammation (1932); Numbness (2415); Coma (2417)

Event Date 01/31/2018

Event Type  Injury  

Manufacturer Narrative

Since the device is not being returned, evaluation for a malfunction is not possible.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.This report is associated with 1819470-2019-00143 since there is more than one device implicated.

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 via a psp, concerned a (b)(6) male patient of an unspecified origin.Medical history included a previous use of a humapen savvio on unspecified dates.Concomitant medications included pregabalin, benfotiamine/ cyanocobalamin/ pyridoxine hydrochloride and hydroxocobalamin; all for the treatment of neuropathy.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) suspension via a reusable pen (humapen savvio gray) and (humapen ergo unknown body type), 30 iu before taking breakfast or lunch and at night (twice daily), subcutaneously for the treatment of diabetes beginning approximately before 2009.Approximately, since 2015, he was experiencing numbness in his toes, so was prescribed with pregabalin firstly once daily, and then his dose was increased to twice daily.Approximately, since 2016 he was experiencing inflammation in his palm joints.On an unspecified date, but during 2018 reportedly he was hungry, but did not eat anything and took his insulin dose which lead to a low blood glucose associated with coma (no units or values were provided).The patient took a juice and recovered.This event of blood glucose associated with coma was considered as serious by the company due to its medical significance.On an unspecified date, approximately, since (b)(6) 2019 he was experiencing high blood glucose levels sometimes reaching 270-280 mg/dl (reference values were not provided).On (b)(6) 2019, it was reported that on an unspecified date the screw of the humapen savvio was not working properly and as a consequence the humapen savvio dispensed an extra dose of insulin (pc: (b)(4) /lot: unknown).The humapen saavio and humapen ergo possibly had been used for more than 3 years.Reportedly, some days he did not miss any doses as he was using the humapen ergo of his sister; he did not have his own spare pen, but he was missing doses when he could not go to her.Approximately since (b)(6) 2019, his humapen ergo started to get stuck, heavy and loose sometimes (pc: (b)(4)/ lot: unknown).In (b)(6) 2018 his blood glucose was high at 300 mg/dl (no reference values were provided).On (b)(6) 2019 he fully recovered from the event of missed doses.Information regarding additional corrective treatment was not provided.The outcome of the events of numbness, joint inflammation, and two episodes of high blood glucose levels was not recovered.He recovered from the event of low blood glucose associated with coma.The outcome of the remaining events was not provided.The treatment with human insulin 70/30 was ongoing.The user of the humapen savvio was the patient but his training status was not provided.The general humapen savvio model duration of use was not provided; the humapen savvio model had been used for more than 4 years.The duration of use for the humapen savvio considered as suspect was not provided, but at the time of initial report, it had been used likely for about 3 or 4 years.The general humapen ergo model duration of use was not provided, the suspect humapen ergo duration of use was approximately three years.The suspect humapen savvio was not returned to the manufacturer.The suspect humapen ergo was discarded in (b)(6) 2019; so its return was not expected.The reporting consumer considered the event of low blood glucose associated with coma as related to the treatment with human insulin 70/30 and did not provide any other opinion of causality between remaining events and human insulin 70/30 treatment.The reporting consumer considered the event of extra dose of insulin as related to the humapen savvio, did not provide an opinion of causality between event of hunger and the humapen savvio and considered the events of numbness, arthritis, blood glucose increased and low blood glucose with coma as not related to the humapen savvio.The reporting consumer related the events of drug dose omission and second episode of blood glucose increased to the humapen ergo.No other opinion of causality was provided.Edit 01aug2019: upon review, the reported date for pc (b)(4) associated with the humapen savvio gray device was added to the case.No other changes were made.Update 07aug2019: additional information received on 05aug2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and (b)(6) (eu/(b)(6)) device information, and device return status to not returned to manufacturer for pc (b)(4) associated to unknown lot of humapen savvio (gray) device.Upon internal review, changed the device age to 4 years.Corresponding fields and narrative updated accordingly.Update 17-sep-2019: additional information received on 10-sep-2019 from the initial reporter via a psp.Added a humapen ergo unknown as suspect device, the new non-serious events of drug dose omission and a second episode of blood glucose increased and laboratory data.Updated dosage regimen of human insulin 70/30 from once daily to twice daily.The narrative was updated with the new information.Edit 25sep2019: updated medwatch fields for expedited device reporting.No new information added.Updated the date of the previous update statement to clarify the month the update statement was written.Edit 30-sep-2019: upon catool reconciliation pc (b)(4) was received, processed and added to the narrative.No changes were made to the 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 dated 04oct2019 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2019-00143 since there is more than one device implicated.Evaluation summary: a male patient reported his humapen ergo device got stuck in (b)(6) 2019; the device was "heavy and loose sometimes." the patient experienced hypoglycemic coma during 2018.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen ergo 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 reported he did not miss any doses as he was using the humapen ergo of his sister.The core user manual states, "do not share your pen or needles as this may risk transmission of infectious agents" and "always carry a spare insulin pen in case your pen is lost or damaged." there is evidence of improper use.The patient used another individual's pen.This is not likely relevant to the event of hypoglycemic coma.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter via a psp, concerned a 53-year-old male patient of an unspecified origin.Medical history included a previous use of a humapen savvio on unspecified dates.Concomitant medications included pregabalin, benfotiamine/ cyanocobalamin/ pyridoxine hydrochloride and hydroxocobalamin; all for the treatment of neuropathy.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) suspension via a reusable pen (humapen savvio gray) and (humapen ergo unknown body type), 30 iu before taking breakfast or lunch and at night (twice daily), subcutaneously for the treatment of diabetes beginning approximately before 2009.Approximately, since 2015, he was experiencing numbness in his toes, so was prescribed with pregabalin firstly once daily, and then his dose was increased to twice daily.Approximately, since 2016 he was experiencing inflammation in his palm joints.On an unspecified date, but during 2018 reportedly he was hungry, but did not eat anything and took his insulin dose which lead to a low blood glucose associated with coma (no units or values were provided).The patient took a juice and recovered.This event of blood glucose associated with coma was considered as serious by the company due to its medical significance.On an unspecified date, approximately, since (b)(6) 2019 he was experiencing high blood glucose levels sometimes reaching 270-280 mg/dl (reference values were not provided).On (b)(6) 2019, it was reported that on an unspecified date the screw of the humapen savvio was not working properly and as a consequence the humapen savvio dispensed an extra dose of insulin ((b)(4)/lot: unknown).The humapen saavio and humapen ergo possibly had been used for more than 3 years.Reportedly, some days he did not miss any doses as he was using the humapen ergo of his sister; he did not have his own spare pen, but he was missing doses when he could not go to her.Approximately since (b)(6) 2019, his humapen ergo started to get stuck, heavy and loose sometimes ((b)(4)/ lot: unknown).In (b)(6) 2019 his blood glucose was high at 300 mg/dl (no reference values were provided).On (b)(6) 2019 he fully recovered from the event of missed doses.Information regarding additional corrective treatment was not provided.The outcome of the events of numbness, joint inflammation, and two episodes of high blood glucose levels was not recovered.He recovered from the event of low blood glucose associated with coma.The outcome of the remaining events was not provided.The treatment with human insulin 70/30 was ongoing.The user of the humapen savvio and the humapen ergo device was the patient but his training status was not provided.The general humapen savvio model duration of use was not provided; the humapen savvio model had been used for more than 4 years.The duration of use for the humapen savvio considered as suspect was not provided, but at the time of initial report, it had been used likely for about 3 or 4 years.The general humapen ergo model duration of use was not provided, the suspect humapen ergo duration of use was approximately three years.The suspect humapen savvio device associated with product complaint (b)(4) was not returned to the manufacturer.The suspect humapen ergo device associated with product complaint (b)(4) was discarded in (b)(6) 2019, thus the device was not returned to the manufacturer.The reporting consumer considered the event of low blood glucose associated with coma as related to the treatment with human insulin 70/30 and did not provide any other opinion of causality between remaining events and human insulin 70/30 treatment.The reporting consumer considered the event of extra dose of insulin as related to the humapen savvio, did not provide an opinion of causality between event of hunger and the humapen savvio and considered the events of numbness, arthritis, blood glucose increased and low blood glucose with coma as not related to the humapen savvio.The reporting consumer related the events of drug dose omission and second episode of blood glucose increased to the humapen ergo.No other opinion of causality was provided.Edit 01aug2019: upon review, the reported date for (b)(4) associated with the humapen savvio gray device was added to the case.No other changes were made.Update 07aug2019: additional information received on 05aug2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, and device return status to not returned to manufacturer for (b)(4) associated to unknown lot of humapen savvio (gray) device.Upon internal review, changed the device age to 4 years.Corresponding fields and narrative updated accordingly.Update 17-sep-2019: additional information received on 10-sep-2019 from the initial reporter via a psp.Added a humapen ergo unknown as suspect device, the new non-serious events of drug dose omission and a second episode of blood glucose increased and laboratory data.Updated dosage regimen of human insulin 70/30 from once daily to twice daily.The narrative was updated with the new information.Edit 25sep2019: updated medwatch fields for expedited device reporting.No new information added.Updated the date of the previous update statement to clarify the month the update statement was written.Edit 30-sep-2019: upon catool reconciliation (b)(4) was received, processed and added to the narrative.No changes were made to the case.Update 04oct2019: additional information received on 03oct2019 and 04oct2019 from the global product complaint database, which was processed together.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information for the suspect humapen ergo device associated with product complaint (b)(4), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.

• Brand Name: HP ERGO
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 9152477
• MDR Text Key: 168021292
• Report Number: 1819470-2019-00180
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K982842
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR