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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 Physical Resistance/Sticking (4012)
Patient Problem Hypoglycemia (1912)
Event Date 12/31/2019
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 solicited case reported by consumer via patient support program (psp) and product complaints (pcs), concerned a (b)(6) year-old (at the time of initial report) female patient of unknown origin. Medical history was not reported. Concomitant medications included pantoprazole and pentoxifylline for gastric disorders, vortioxetine hydrobromide and dexamethasone for memory impairment, ezetimibe and simvastatin for neuro disorders, memory impairment and blood circulation, bisoprolol fumarate and ramipril for hypertension, clopidogrel bisulfate for cardiac disorder, metformin hydrochloride and vildagliptin for liver and pancreas disorders. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin mix 70/30) from cartridge via reusable humapen devices at a dose of 30 units in the morning and 10 units at night twice daily subcutaneously for the treatment of diabetes mellitus beginning on an unknown date in 2015. Approximately in 2017, she had replaced her humapen unknown device with humapen ergo ii. Intermittently on an unspecified onset and time, while on human insulin isophane suspension 70%/human insulin 30%, her blood glucose level was sometimes unstable, in which it sometimes decreased to the range of 70-100 mg/dl if she refused to eat or refused to complete her proper meal. In (b)(6) 2019, she experienced severe hypoglycemia and her blood glucose reached to 20 mg/dl. She was hospitalized for hypoglycemia to maintain the blood glucose level. After five days of hospitalization, she recovered. On (b)(6) 2020, her humapen ergo ii plunger had stuck and does not move up or down and the insulin was heavily dispensed, however the complete doses are administered but with difficulty. On (b)(6) 2020, her humapen ergo ii had been completely impaired but no doses were missed. Information regarding corrective treatment for the events was not reported. She was not recovered from the event unstable blood glucose (decreased). Human insulin isophane suspension 70%/human insulin 30% was continued. The patient was operator of the humapen unknown device and humapen ergo ii and her training status was unknown. The general humapen unknown device model duration of use and suspect duration of use was not provided. The general humapen ergo ii model duration of use and suspect humapen ergo ii model duration for use were noted to be approximately 34 months (beginning around (b)(6) 2017). There was no reported complaint for humapen unknown device and its return was not expected the patient continued to use humapen ergo ii and its return was expected. The reporting consumer did not know if the event unstable blood glucose was related or not to insulin human insulin isophane suspension 70%/human insulin 30% and did not considered the event of severe hypoglycemia to human insulin isophane suspension 70%/human insulin 30%. The reporting consumer did not relate events to humapen devices. Edit 16mar2020: updated medwatch 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, 46285
Manufacturer (Section G)
PHILLIPS-MEDISIZE CORPORATION
415 red cedar street
medical device manufacturing
menomonie,
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, in 
MDR Report Key9856453
MDR Text Key188255605
Report Number1819470-2020-00021
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 04/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Device Lot Number0909D01
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2009
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: 03/19/2020 Patient Sequence Number: 1
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