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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 Hyperglycemia (1905); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
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 as necessary.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint, concerned a male patient of an unknown age and origin. Medical history, drug adverse reaction and family drug adverse reaction were unknown. Concomitant medications were not reported. The patient received an unspecified human insulin (rdna origin) (humulin 3 ml:300 iu) from a cartridge via an unknown humapen device, for the treatment of diabetes mellitus and beginning on an unknown date. Dose, units, frequency and route of administration were not provided. Since an unspecified date, while on human insulin therapy, he was experiencing high blood glucose many times and also had uncomfortable heart. Sometimes he was hospitalized because of high blood glucose and uncomfortable heart (dates not provided). On an unknown date, during hospitalization, he was checked out with high blood lipid. He was last hospitalized on (b)(6) 2017 due to high blood glucose. The information regarding any corrective treatment, further hospitalization dates and details and outcome of the events was not provided. Human insulin therapy was ongoing. The operator of humapen unknown device and his/her training status were not provided. The general humapen (unknown device) duration of use and the suspect humapen duration of use were not provided. Action taken with the suspect humapen was not provided and its return status was unknown. The initial reporting consumer did not know if the events were related to human insulin (unknown formulation) therapy or humapen unknown device. Edit 24may2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting on 10may2018. 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 Key7543175
MDR Text Key109308966
Report Number1819470-2018-00089
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K151686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9557
Device Lot Number1208D02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2012
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: 05/24/2018 Patient Sequence Number: 1
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