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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
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Fell (4014)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
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 (b)(6) (at the time of initial report) chinese han patient of unknown gender. Medical history was not provided. Concomitant medications included the use of metformin for the treatment of an unknown indication. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) from a cartridge, via a reusable pen (unknown), subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2001. On an unknown date, while on the therapy with human insulin isophane suspension 70%/human insulin 30%, the patient had high blood glucose and high blood pressure due to which the patient was hospitalized on (b)(6) 2021. As on (b)(6) 2021, the patient was still in the hospital. Information regarding corrective treatment and outcome of events was not provided. Therapy status with human insulin isophane suspension 70%/human insulin 30% was not provided. No additional follow-up would be pursued, as the reporter refused further follow-up and the physician contact information was unknown. The operator of the device was the patient and his/her training status was not provided. The general device duration of use and suspect device duration of use was not provided. The issue with the suspect humapen had been not been resolved and its return was expected. The initial reporting consumer assessed the relatedness of the event to the human insulin isophane suspension 70%/human insulin 30% therapy as unknown. The initial reporting consumer did not provide the relatedness assessment of the events to the device use. Edit 07-jan-2022: updated medwatch fields for expedited device reporting and added contact log accordingly. No new information added. Edit 12-jan-2022: corrected suspect device name in device use paragraph in the narrative.
 
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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 Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key13235785
MDR Text Key289001586
Report Number1819470-2021-00181
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received01/11/2022
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: 01/12/2022 Patient Sequence Number: 1
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