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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 Mechanical Problem (1384)
Patient Problem No Code Available (3191)
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
(b)(4). This spontaneous case, reported by consumers who contacted the company to report adverse events and product complaint (pc), concerned a (b)(6) female patient of (b)(6) nationality. Medical history included no comorbidity. Drug adverse reaction history and family drug adverse reaction were not provided. Concomitant medication included metformin, acarbose, repaglinide and gelieshuangpi (as reported) for type 2 diabetes mellitus. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100 u/ml) from cartridges via reusable pen (humapen ergo ii), twice daily (morning 22 units, night 22 units) subcutaneously for the treatment of type 2 diabetes mellitus, beginning on an unknown date (from many years ago). In 2018, after starting human insulin isophane suspension 70%/human insulin 30% therapy, she was tested in the community welfare examination for the elderly. The various assay indicators were not very good (checked for assays such as cholesterol, triglyceride, urine protein and so on), and the doctor recommended hospitalization. The events of cholesterol abnormal, triglyceride abnormal and urine protein were considered serious due to medical significance. On an unknown date, she had high blood sugar. Reportedly, the injection button of a humapen ergo ii cannot be pushed down ((b)(4)/ lot number 1612d03). In (b)(6) 2018, because of high blood sugar, she was hospitalized for nearly half a month. After the hospitalization, she underwent a systemic check assay. The test indicator of kidney were relatively high (not very good) and check assays for cholesterol, triglycerides, and urine protein were still not good. So, she discontinued human insulin isophane suspension 70%/human insulin 30% according to the doctors advice and switched to insulin lispro series insulin. On an unknown date, her physical condition was recovering and she had been discharged from the hospitalisation. Information regarding corrective treatment was not provided. It was unknown that if the human insulin isophane suspension 70%/human insulin 30% therapy would be restarted. The operator of the humapen ergo ii and his/her training status were not provided. The humapen ergo ii model duration of use and suspect humapen ergo ii were not provided. The use of the suspect humapen ergo ii was continued and its return status was not provided. The reporting consumers did not know if the events were related to human insulin isophane suspension 70%/human insulin 30% and did not provide a relatedness assessment for the events to humapen ergo ii. Update 25-jul-2018: no new medically significant information received on 24-jul-2018. No other changes were made to case. Edit 26jul2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting. No new information added.
 
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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 Key7757947
MDR Text Key116535648
Report Number1819470-2018-00126
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,Followup
Report Date 09/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number1612D03
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/31/2016
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: 08/07/2018 Patient Sequence Number: 1
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