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

Model Number MS9557

Device Problems Difficult or Delayed Activation (2577); Mechanical Jam (2983)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 05/31/2020

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 spontaneous case reported by a consumer, with additional information from the same initial reporter, who contacted the company to report an adverse event concerned a (b)(6) asian female patient.Medical history was not provided.Her father had diabetes mellitus.Concomitant medications included metformin and glimepiride both for unknown indications.The patient received insulin lispro (humalog), cartridge, at unknown dose, frequency and route of administration, for the treatment of diabetes mellitus, from around 2000 and also received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 25), cartridge three times daily (8 units in the morning, 6 units in the noon, and 16 units at night) subcutaneously for the treatment of diabetes mellitus beginning in about 2004.The patient used humapen ergo ii since 2011 to (b)(6) 2021(unclear which insulin was used with this device or if both were delivered by this device).On unknown date around 2017, approximately 17 years since the beginning of the treatment with insulin lispro and 14 years since beginning of the treatment with insulin lispro protamine suspension 75%/insulin lispro 25%, the patient had retinal detachment and could see (as reported).However, in (b)(6) 2019, the patient's eyes were not good and she had an operation.Since unspecified dates, the patient had high blood glucose and she was hospitalized every year to regulate the blood glucose.From (b)(6) 2020, while on insulin lispro protamine suspension 75%/insulin lispro 25% and insulin lispro treatments, the blood glucose was not well controlled and as of (b)(6) 2020, the blood glucose was still very high every day; the fasting blood glucose was especially high since the patient had diabetes mellitus.The patient was advised to seek medical advice in time to find out the cause, and follow the advice of the doctor and guidance for rational drug use.The doctor had asked the patient to change the therapy to use insulin aspart.Additionally, on (b)(6) 2021, the humapen ergo ii button could not be pressed even after replacing the needle to prime (lot number was not provided; product complaint number: 5735457).It was also reported that patient had difficulty in speaking and could not see clearly the lot number the information of humapen ergo ii.The events of eyes were not good/could not see clearly and retinal detachment were considered as serious by the company due to medical significance.She had not recovered from the events of high blood glucose, eye not good/could not see and retinal detachment.Information regarding further details of hospitalization, corrective treatments and outcome of remaining event were not reported.Status of insulin lispro protamine suspension 75%/insulin lispro 25% treatments and insulin lispro was unknown.It was unknown who operated the device and if the operator was trained.The duration for use for this device model and the duration for use for this reported suspect device was unknown.The reported suspect device was discontinued on (b)(6) 2021 and its return status was unknown the reporting consumer did not know whether the events blood glucose increased, and eyes not good/could not see were related to insulin lispro protamine suspension 75%/insulin lispro 25% therapy and did not know if the retinal detachment was related to insulin lispro.No other relatedness opinion was reported.Update 11oct2021: additional information received on 30sep2021 from initial reporter, via psp.Added serious event of retinal detachment; updated the serious event coding from eye disorder to visual impairment; added non-serious event of difficulty in speaking; added insulin lispro (humalog) as suspect drug and humapen ergo ii as suspect device; minor amendment performed in the narrative.Corresponding fields and narrative were updated accordingly.Update 14-oct-2021: additional information received from the initial reporter on 08-oct-2021.Added dosage regimen and therapy stop date of insulin lispro, onset date of event retinal detachment.Updated action taken of insulin lispro from no change to unknown.A duplicate product complaint (b)(4) was received and processed accordingly added a second humapen ergo ii suspect device to process duplicate (b)(4).Updated causality statement and narrative with new information.Edit 25oct2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Update 26oct2021: additional information received on 25oct2021 from global product complaint database cancelled the product (b)(4).The complaint number was removed from the product tab for the humapen ergo ii device.

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 04nov2021 in the b.5.Field.No further follow-up is planned.Evaluation summary.A female patient reported that her humapen ergo ii button could not be pressed even after replacing the needle to prime.She experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch number unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The patient reported visual impairment.The core instructions for use state 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 patient used the device while visually impaired.It is unknown if this misuse is relevant to the complaint or event of increased blood glucose.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case reported by a consumer, with additional information from the same initial reporter, who contacted the company to report an adverse event concerned a 55-year-old asian female patient.Medical history was not provided.Her father had diabetes mellitus.Concomitant medications included metformin and glimepiride both for unknown indications.The patient received insulin lispro (humalog), cartridge, at unknown dose, frequency and route of administration, for the treatment of diabetes mellitus, from around 2000 and also received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 25), cartridge three times daily (8 units in the morning, 6 units in the noon, and 16 units at night) subcutaneously for the treatment of diabetes mellitus beginning in about 2004.The patient used humapen ergo ii since 2011 to 03-sep-2021(unclear which insulin was used with this device or if both were delivered by this device).On unknown date around 2017, approximately 17 years since the beginning of the treatment with insulin lispro and 14 years since beginning of the treatment with insulin lispro protamine suspension 75%/insulin lispro 25%, the patient had retinal detachment and could see (as reported).However, in (b)(6) 2019, the patient s eyes were not good and she had an operation.Since unspecified dates, the patient had high blood glucose and she was hospitalized every year to regulate the blood glucose.From (b)(6) 2020, while on insulin lispro protamine suspension 75%/insulin lispro 25% and insulin lispro treatments, the blood glucose was not well controlled and as of (b)(6) 2020, the blood glucose was still very high every day; the fasting blood glucose was especially high since the patient had diabetes mellitus.The patient was advised to seek medical advice in time to find out the cause, and follow the advice of the doctor and guidance for rational drug use.The doctor had asked the patient to change the therapy to use insulin aspart.Additionally, on (b)(6) 2021, the humapen ergo ii button could not be pressed even after replacing the needle to prime (lot number was not provided; product complaint number: (b)(4)).It was also reported that patient had difficulty in speaking and could not see clearly the lot number the information of humapen ergo ii.The events of eyes were not good/could not see clearly and retinal detachment were considered as serious by the company due to medical significance.She had not recovered from the events of high blood glucose, eye not good/could not see and retinal detachment.Information regarding further details of hospitalization, corrective treatments and outcome of remaining event were not reported.Status of insulin lispro protamine suspension 75%/insulin lispro 25% treatments and insulin lispro was unknown.It was unknown who operated the device and if the operator was trained.The duration for use for this device model and the duration for use for this reported suspect device was unknown.The reported suspect device was discontinued on 03sep2021 and it was not returned to manufacturer.The reporting consumer did not know whether the events blood glucose increased, and eyes not good/could not see were related to insulin lispro protamine suspension 75%/insulin lispro 25% therapy and did not know if the retinal detachment was related to insulin lispro.No other relatedness opinion was reported.Update 11oct021: additional information received on 30sep2021 from initial reporter, via psp.Added serious event of retinal detachment; updated the serious event coding from eye disorder to visual impairment; added non-serious event of difficulty in speaking; added insulin lispro (humalog) as suspect drug and humapen ergo ii as suspect device; minor amendment performed in the narrative.Corresponding fields and narrative were updated accordingly.Update 14-oct-2021: additional information received from the initial reporter on 08-oct-2021.Added dosage regimen and therapy stop date of insulin lispro, onset date of event retinal detachment.Updated action taken of insulin lispro from no change to unknown.A duplicate product complaint number (b)(4) was received and processed accordingly added a second humapen ergo ii suspect device to process duplicate (b)(6).Updated causality statement and narrative with new information.Edit 25oct2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 26oct2021: additional information received on 25oct2021 from global product complaint database cancelled the product complaint number (b)(4).The complaint number was removed from the product tab for the humapen ergo ii device.Update 03nov2021: additional information received on 02nov2021 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields, improper use and storage from no to yes, and device not returned to manufacturer for the suspect device with pc 5735457 associated with an unknown lot.Corresponding fields and narrative updated accordingly.

• 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): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285
• MDR Report Key: 12725453
• MDR Text Key: 282619778
• Report Number: 1819470-2021-00142
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2021
• 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 Sex: Female
• Patient Weight: 40 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian