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U.S. Department of Health and Human Services

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

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ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES Back to Search Results
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.
 
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Brand NameHUMAPEN ERGO II
Type of DeviceFOR 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 Key8865644
MDR Text Key153950672
Report Number1819470-2019-00136
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K151686
Number of Events Reported1
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 Received08/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2019
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 Treatment Data
Date Received: 08/06/2019 Patient Sequence Number: 1
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