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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN, UNKNOWN DEVICE FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN, UNKNOWN DEVICE FOR TREATMENT PURPOSES Back to Search Results
Model Number UNKNOWN
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908)
Event Date 09/13/2015
Event Type  Injury  
Manufacturer Narrative
Product complaint: pending. If device is returned, evaluation will be performed to determine if a malfunction has occurred. A follow-up report will be submitted when the final evaluation is completed.
 
Event Description
(b)(4) this report is associated with product complaint: pending. This solicited case, reported by a consumer via a patient support program (psp), concerned an (b)(6) chinese female patient. Medical history included heart disease, high blood pressure and hyperlipidemia. Concomitant medications included losartan potassium for an unspecified indication. The patient received human insulin isophane suspension (rdna origin) (humulin n) cartridges, 9 units in the morning and 2 to 3 units before sleep, and human insulin (rdna origin) (humulin r) cartridges, 6 units in the morning and 5 units in the evening; both via a reusable pen (humapen unknown body type), subcutaneously for the treatment of diabetes mellitus, start date for any of the therapies was not provided. Since (b)(6)-2015, she adjusted her human insulin isophane suspension to only 9 units in the morning (no details were provided). On (b)(6)-2015, she experienced a fracture due to a fall caused by hypoglycemia. On an unknown date, she was hospitalized and then changed human insulin isophane suspension and human insulin to insulin lispro with insulin detemir. On (b)(6)-2016, she was discharged from hospital. No details regarding admission date, treatment and laboratory tests done while hospitalized were provided. Information regarding corrective treatment and events outcome was not provided. She was the operator of the device and her training status was not provided. The device model and reported device duration of use were not reported. If device would be returned, evaluation would be performed to determine if a malfunction has occurred. The consumer reporter did not know if the events were causally related to human insulin isophane suspension and human insulin therapies, and did not provide any relatedness opinion between any of the events and the device. Edit 30mar2016. Case was opened to enter medwatch device fields for device mailing. No new information.
 
Manufacturer Narrative
There was no reported complaint for this device and its return is not expected. This is a downgrade report, which no longer meets the criteria for expedited reporting. No further follow up is planned.
 
Event Description
(b)(4). This solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter, concerned an (b)(6) female patient. Medical history included heart disease, high blood pressure and hyperlipidemia. Concomitant medications included losartan potassium for an unspecified indication. The patient received human insulin isophane suspension (rdna origin) (humulin n) cartridges, 9 units in the morning and 2 to 3 units before sleep, and human insulin (rdna origin) (humulin r) cartridges, 6 units in the morning and 5 units in the evening; both via a reusable pen (humapen unknown body type), subcutaneously for the treatment of diabetes mellitus; start date for any of the therapies was not provided. Since (b)(6) 2015, she adjusted her human insulin isophane suspension to only 9 units in the morning (no details were provided). On (b)(6) 2015, she decreased her intake of carbohydrates and protein; therefore, she started feeling dizzy and she experienced a hypoglycemia episode, later on, she lost her consciousness (the event of loss of consciousness was considered serious due to medical significance). Because of her hypoglycemia episode, she fell and she broke her haunch bone for which she needed to be admitted to the hospital on an unspecified date, and she underwent an unspecified surgery for her fracture. During hospitalization, she was switched from human insulin isophane suspension and human insulin to insulin lispro with insulin detemir. On (b)(6) 2016, she was discharged from hospital. No details regarding admission date, treatment and laboratory tests done while hospitalized were provided. Information regarding further corrective treatments and events outcome was not provided. She was the operator of the device and her training status was not provided. The humapen model and reported humapen duration of use were not reported. There was no reported complaint for the suspect device; therefore the device would not be returned. There was no improper use or storage for this device. The reporting consumer did not provide an opinion of relatedness for the event of loss of consciousness. The reporting consumer did not know if the remaining events were causally related to human insulin isophane suspension and human insulin therapies, and did not provide any relatedness opinion between any of the events and the device. Edit 30mar2016. Case was opened to enter medwatch device fields for device mailing. No new information. Update 06-apr-2016: additional information was received from the initial reporter on 31-mar-2016 via psp. Added: serious event of loss of consciousness. Serious event of fracture was updated to hip fracture. Narrative was updated accordingly. Edit 14-apr-2016: recoded study products for expedited reporting purposes. Update 03jun2016: additional information received on 10may2016 clarified that there was no reported complaint for the suspect device. The preliminary comments for the device, european and canadian required device reporting elements, and the medwatch fields were updated due to the clarification that there was no product complaint associated with the suspect humapen. The narrative was updated.
 
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Brand NameHUMAPEN, UNKNOWN DEVICE
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
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key5543753
MDR Text Key41738938
Report Number1819470-2016-00078
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 03/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2016
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: 04/04/2016 Patient Sequence Number: 1
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