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

Model Number MS9557

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Hyperglycemia (1905); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Description of problem or event: new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 05aug2019.No further follow-up is planned.Evaluation summary: the reporter stated the patient started to use the humapen ergo more than 10 years and it was also noted her eyes did not see clearly.There was no product complaint for the device and the device was not returned for investigation.There was evidence of improper use of the device.It was reported that the device was used for more than 10 years and the patient used the device while her eyes did not see clearly.The user manual states humapen ergo ii device has been designed to be used for up to 3 years after first use and not recommended for the blind or visually impaired without the assistance of a sighted individual trained to use it.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint (pc), concerns a (b)(6)-year-old female (at the time of initial report) patient of unspecified origin.Medical history included cerebral infarction.Concomitant medication included acarbose and metformin for diabetes mellitus.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) cartridge via reusable humapen ergo ii (humapen blue), 18 units before sleep, subcutaneously, for the treatment of diabetes mellitus, beginning approximately in 2009 (reportedly since more than ten years ago.On unspecified date, her blood glucose was unstable (preprandial blood glucose value was 8-9; postprandial blood glucose value was 13-15 and also postprandial blood glucose value was 17-18).Therefore, her physician increased her dose of human insulin isophane suspension 70%/human insulin 30% from 18 units before sleep to 20 units before sleep.Due to blood glucose increased, the complications was fundus hemorrhage and the eye did not see clearly.The events blood glucose increased and fundus hemorrhage were consider serious for being medically significant.On (b)(6) 2019, due to cerebral infarction she was hospitalized.No further information regarding hospitalization was provided.On (b)(6) 2019, due to cerebral infarction, she underwent stent and was discharged on (b)(6) 2019.On unspecified date, she not want to eat meal, stomach was not good and she was thinner 15 kg.On (b)(6) 2019, she was hospitalized due to hand and foot numbness.No further information regarding hospitalization was provided.On unspecified date hand and foot numbness was recovered.On (b)(6) 2019, she was discharged from hospital.On (b)(6) 2019, the pen body was damaged.Treatments for the remaining events and outcomes of the remaining events were not provided.Human insulin isophane suspension 70%/human insulin 30% was continued.The operator of the device was the patient and her training status was unknown.The general device model duration and the suspect device duration of use were noted to be more than 10 years ago (beginning around 2009).The suspect humapen ergo ii device was not returned to the manufacturer.The reporting consumer did not know if the events were related to human insulin isophane suspension 70%/human insulin 30% treatment or not.Update 18-jul-2019: information was received from the affiliate on 16-jul-2019.Tr number was received and pc was processed accordingly.No medically significant information was added to the case.Edit 24-jul-2019: upon internal review of the information received on 16-jul-2019, pc description was added in narrative, device age was updated to 10 years and improper use was updated from no to yes.Edit 24-jul-2019: case was reopened in order to add the corresponding fu date of the previous edit.No further changes were made.Update 05aug2019: upon further review of the adverse event and product complaint temporal relationship, (b)(4) could not have caused or contributed to the serious adverse event as the serious adverse event occurred prior to the pc; thus (b)(4) was reprocessed accordingly.Entered a device specific safety summary (dsss).Added medwatch and european and (b)(4) (eu/(b)(4)) fields for the suspect humapen ergo ii device, which was not returned to the manufacturer.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): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 8865644
• MDR Text Key: 153950672
• Report Number: 1819470-2019-00136
• 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: consumer,foreign
• Type of Report: Initial
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2019
• 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): Other
• Patient Age: 77 YR
• Patient Weight: 59