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

Model Number MS9557

Device Problems No Audible Prompt/Feedback (2282); Activation Problem (4042)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 01/31/2012

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4) this spontaneous case, reported by a consumer who contacted the company to report adverse events, concerned an asian female patient of unknown age of (b)(6).The medical history and concomitant medication were not provided the patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injection (humalog mix25, 100u/ml) from cartridge via reusable pen humapen ergo ii, 10 units once every night, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2012.On an unknown date in 2012, while on insulin lispro therapy she experienced blood glucose was suddenly high and suddenly low, and it was unstable (units, values and reference range was not provided).On an unknown date in 2012, she was hospitalized due to blood glucose unstable.Then the patient followed the physician advice to stop the medicine in around 2012.The symptom was not relieving.On an unknown date in 2018, she started the insulin lispro protamine suspension 75%/insulin lispro 25% therapy following the physician advice.She was advised to take 12 units twice a day (morning and night).It was also reported that she would inject less if blood glucose was low (the units of injecting less was unclear), it did not exceed 12 units every time when blood glucose was high.It was reported that the injection button of an humapen ergo ii could be depressed directly to the end without click sound (pc# (b)(4) / lot# 1109d02; pc# (b)(4)/ lot# 1806d01).Information regarding corrective treatment and outcome of remaining events were not provided.The status of insulin lispro protamine suspension (b)(4) treatment was not provided.The operator of the humapen ergo ii devices and his/her training status was not provided.The device model, duration of use was not provided but were started on an unspecified date in 2012 and 2018 respectively, and the suspect devices duration of use were one year.The action taken with the suspect device was not provided and their return was expected.The initial reporting consumer assessed the relatedness of the events with the insulin lispro protamine suspension 75%/insulin lispro 25% treatment as unknown, while did not provide the relatedness assessment of the events with the humapen ergo ii devices.Update 14jan2022: additional information received on 10jan2022 from global product complaint database.Updated lot number from unknown to 1109d02 for product complaint number (b)(4) relating to the suspect humapen ergo ii device.Corresponding fields and narrative updated accordingly.Update 21jan2022: additional information received on 20jan2022 from global product complaint database.Updated lot number from unknown to 1806d01 for product complaint number (b)(4) relating to the suspect humapen ergo ii device.Corresponding fields and narrative updated accordingly.Edit 03feb2022: updated medwatch fields for expedited device reporting and added contact log accordingly.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.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events, concerned an asian female patient of unknown age of (b)(6) nationality.The medical history and concomitant medication were not provided.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injection (humalog mix25, 100u/ml) from cartridge via reusable pen humapen ergo ii, 10 units once every night, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2012.On an unknown date in 2012, while on insulin lispro therapy she experienced blood glucose was suddenly high and suddenly low, and it was unstable (units, values and reference range was not provided).On an unknown date in 2012, she was hospitalized due to blood glucose unstable.Then the patient followed the physician advice to stop the medicine in around 2012.The symptom was not relieving.On an unknown date in 2018, she started the insulin lispro protamine suspension 75%/insulin lispro 25% therapy following the physician advice.She was advised to take 12 units twice a day (morning and night).It was also reported that she would inject less if blood glucose was low (the units of injecting less was unclear), it did not exceed 12 units every time when blood glucose was high.It was reported that the injection button of an humapen ergo ii could be depressed directly to the end without click sound (pc# (b)(4) / lot# 1109d02; pc# (b)(4) / lot# 1806d01).Information regarding corrective treatment and outcome of remaining events were not provided.The status of insulin lispro protamine suspension 75%/insulin lispro 25% treatment was not provided.The operator of the humapen ergo ii devices and his/her training status was not provided.The device model, duration of use was not provided but were started on an unspecified date in 2012 and 2018 respectively, and the suspect devices duration of use were one year.The action taken with the suspect device was not provided.The device was returned to manufacturer and there was no malfunction identified.The initial reporting consumer assessed the relatedness of the events with the insulin lispro protamine suspension 75%/insulin lispro 25% treatment as unknown, while did not provide the relatedness assessment of the events with the humapen ergo ii devices.Update 14jan2022: additional information received on 10jan2022 from global product complaint database.Updated lot number from unknown to 1109d02 for product complaint number (b)(4) relating to the suspect humapen ergo ii device.Corresponding fields and narrative updated accordingly.Update 21jan2022: additional information received on 20jan2022 from global product complaint database.Updated lot number from unknown to 1806d01 for product complaint number (b)(4) relating to the suspect humapen ergo ii device.Corresponding fields and narrative updated accordingly.Edit 03feb2022: updated medwatch fields for expedited device reporting and added contact log accordingly.No new information added.Update 21feb2022: additional information received on 17feb2022 from the global product complaint database.Entered device specific safety summary (dsss) and updated the medwatch fields/ european and canadian (eu/ca) device information for humapen ergo ii (lot number 1806d01) associated with product complaint (b)(4) which was returned to the manufacturer.The date of manufacture and date returned to manufacturer was updated.Device malfunction was updated from unknown to no.Corresponding fields and narrative updated accordingly.

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 21feb2022 in the b.5.Field.No further follow-up is planned.This is a downgrade report, no malfunction and no ius was confirmed from dsss.Evaluation summary: a female patient reported that the injection button of her humapen ergo ii device "could be depressed directly to the end without click sound." the patient experienced blood glucose fluctuation.The investigation of the returned device (batch 1806d01, manufactured june 2018) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.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: 13445968
• MDR Text Key: 289602315
• Report Number: 1819470-2022-00001
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1806D01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• 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 Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian