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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 Syncope (1610); Hypoglycemia (1912); Unspecified Infection (1930); Loss of Vision (2139); Burning Sensation (2146); 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
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This solicited case, reported by a consumer via patient support program (psp), concerned a (b)(6) (at the time of initial report) female patient of an unspecified origin. Medical history included diabetes mellitus since 1999 and hypertension. Concomitant medication was not provided. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from unknown formulation via humapen ergo ii, of unknown dose, frequency, indication for use and route of administration beginning on an unknown date in 2004 or 2009 (conflicting start date). On an unknown date while on human insulin isophane suspension 70%/human insulin 30% therapy, due to diabetes mellitus (pre-existing) her sight had been lost. On an unknown date upon injection the humapen ergo ii left a bluish color in the area of injection. The event of diabetic blindness was considered as serious by the company due to medically significant reason. On an unknown date in 2011, while on the human insulin isophane suspension 70%/human insulin 30% she suffered from unspecified kidney disease. On an unknown date in 2014, she was suffering from the burning sensation and pus in urine. On an unknown date while being on teriparatide therapy she had kidney stone. Her kidney was collecting stones. On an unknown date in 2013, due to kidney stone, burning sensation in urine and urine pus, surgery was performed and one kidney was removed. She lived with one kidney. Two surgery was performed one in 2013 and the second followed it by two months. Second surgery was made as part of the kidney was not completely removed so her physician decidedly made the second surgery to remove it completely. On an unknown date while being on human insulin isophane suspension 70%/human insulin 30% therapy she had drop in blood glucose(values, units and reference ranges were not provided) so fainted sometimes accompanied by shivering. Event of burning sensation in urine, pus in urine, kidney stone, faint, blood glucose decreased and shivering was considered as serious by the company due to its medical significance reason. The information regarding the corrective treatment, outcome of events and status of human insulin isophane suspension 70%/human insulin 30% therapy was not provided. The operator of humapen ergo ii and his/her training status was not provided. General device and suspect device duration should be approximately 10 years. The action taken of humapen ergo ii was not provided and if it was returned, evaluation would be performed to determine if a malfunction had occurred. The initial reporting consumer did not provide the relatedness of events to human insulin isophane suspension 70%/human insulin 30% therapy and to humapen ergo ii. Update 12-jun-2019: additional information was received from initial reporter via psp on 09-jun-2019. Updated therapy start date as conflicting 2004 and 2009. Added a lab data of blood glucose decreased, medical history, serious event of pus in urine, kidney stone, burning sensation in urination, faint, blood glucose decreased, shivering and added non serious event of kidney disease. Updated narrative with new information. Edit 19jun2019: updated medwatch and european and (b)(4) (eu/(b)(4)) 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 Key8748614
MDR Text Key149655154
Report Number1819470-2019-00118
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 08/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number0803D08
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2008
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: 07/01/2019 Patient Sequence Number: 1
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