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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infarction, Cerebral (1771); Ischemia (1942); Dizziness (2194); Ischemic Heart Disease (2493); Ambulation Difficulties (2544)
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 30jul2019. No further follow-up is planned. Evaluation summary: a male patient reported that his humapen ergo ii device was dropped and broken due to poor eyesight. He was concerned this would affect the injection of insulin. The patient 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 and dose accuracy with high probability. The patient reported that he has visual impairment. The core instructions for use states 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 is relevant to the event of increased blood glucose.
 
Event Description
Lilly case id: (b)(4). This report is associated with product compliant: (b)(4). This solicited case reported by a consumer via patient support program (psp) concerned a (b)(6)-years-old asian male patient. Medical history included renal problem, brain problem, heart disease/ischemia myocardial and cerebral infarction since 2018 and his mother and elder brother had diabetes mellitus. Concomitant medications included metformin, glibenclamide and xiaoke (as reported); all used for type two diabetes mellitus. The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injection (humalog 25, 100u/ml) from a cartridge via a reusable pen humapen ergo ii, 25 units each morning and 25 units each night, subcutaneously for the treatment of type two diabetes mellitus, beginning approximately on an unknown date in 2017. On an unknown date, while on the insulin lispro protamine suspension 75%/insulin lispro 25% therapy, he had diabetic complications. Also, his blood glucose fluctuated greatly and was not well controlled (sometimes high and sometimes was low). On an unknown date, while on the insulin lispro protamine suspension 75%/insulin lispro 25% therapy, he was hospitalized for heart disease/ischemia myocardial and cerebral infarction. The cause of heart disease and cerebral infarction was that the blood glucose level was not well controlled (sometimes was high and sometimes was low). Also, he felt dizzy and walking unsteadily due to cerebral infarction and heart disease/ischemia myocardial. On an unspecified date, due to cerebral insufficiency and high blood glucose (no reference range was provided), he was hospitalized. Information regarding further hospitalization details, corrective treatment and outcome of the events was not provided. Therapy with insulin lispro protamine suspension 75%/insulin lispro 25% was continued. The operator of the humapen ergo ii was unknown and his/her training status was not provided. The general humapen ergo ii model duration of use was not provided however it was started in 2017 and the suspect humapen ergo ii duration of use was not reported. The action taken with the suspect humapen ergo ii was not provided and its return was not expected. The initial reporting consumer did not provide an assessment of relatedness between the events and insulin lispro protamine suspension 75%/insulin lispro 25% therapy or humapen ergo ii. This case was cross referenced with case (b)(4) (same patient). Update 28-dec-2018: information was received from the affiliate on 27-dec-2018 from affiliate via psp. Pc number was received. No medically significant information was added to the case. Update 11-jan-2019: additional information was received from the initial reporter on 10-jan-2019 via the psp. Added a medical history of cerebral infarction, onset date of medical history heart disease and two non-serious events of felt dizzy and walking unsteadily. Updated verbiage of medical history from heart disease to heart disease/ischemia and its coding from heart disorder to ischemia myocardial, verbiage of the event heart disease to possible heart disease/ischemia myocardial worsening and its coding from heart disorder to ischemia myocardial, verbiage of the event cerebral infarction to possible cerebral infarction worsening, verbiage of the event blood glucose level not well controlled (sometimes high and sometimes was low) to blood glucose level not well controlled/blood glucose fluctuated greatly (sometimes high and sometimes was low) and narrative with new information. Update 16-jul-2019: additional information was received from the initial reporter on 10-jul-2019 via the psp. Added: medical history: renal problem, brain problem; lab test of blood glucose and serious events: high blood glucose and cerebral insufficiency. Updated the therapy start date and dose of suspect drug. Updated the narrative with new information. Edit 23jul2019: updated medwatch fields for expedited device reporting. No new information added. Update 30jul2019: additional information received on 26jul2019 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields with device information, the european and (b)(4) (eu/(b)(4)) device information, and improper use and storage from no to yes for the suspect humapen ergo ii device associated with product complaint (b)(4), which was not returned to the manufacturer. Corresponding fields and narrative updated accordingly. Upon review, suspect device age was updated within the narrative from unknown to one year. Update 30jul2019: upon review, case priority was updated accordingly. Update 06aug2019: additional information received on 06aug2019 from the global product complaint database. No new information was added. Edit 06aug2019: upon internal review of information received on 06aug2019 from the global product complaint database, updated the date last updated field for the dsss for the suspect device 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 Key8875731
MDR Text Key154003734
Report Number1819470-2019-00138
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 company representative,consum
Type of Report Initial,Followup
Report Date 06/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2019
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 Received05/14/2020
Was Device Evaluated by Manufacturer? No
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: 08/08/2019 Patient Sequence Number: 1
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