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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 Device Operates Differently Than Expected (2913)
Patient Problem Hyperglycemia (1905)
Event Date 02/24/2018
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 device only case, reported by a consumer who contacted the company to report an adverse event and a product complaint, concerned a (b)(6) asian male patient. Medical history, previous drug adverse reaction and family drug reaction were none. Concomitant medications were not provided. The patient began taking unspecified insulin (eli-lilly) at 10 units in morning, noon and night respectively, for the treatment of diabetes mellitus, beginning in 2017, via a humapen ergo ii beginning in 2017. On (b)(6) 2018, while using the humapen ergo ii, his blood glucose was high as 29 (units not provided) and he was hospitalized. On an unknown date in (b)(6) 2018, the thread part of humapen ergo ii was broken due to fallen down ((b)(4), lot # unknown). Information regarding corrective treatment, outcome of the event, status of the unspecified insulin was not provided. The humapen ergo ii was discontinued in (b)(6) 2018. The user of the humapen ergo ii was patient and his training status was not provided. The general humapen ergo ii duration of use was not provided but it was started in 2017. The suspect humapen ergo ii duration of use were not provided. The action taken with the humapen ergo ii was not provided and its return was expected. The reporting consumer did not know relatedness between event and humapen ergo ii. Edit 15mar2018: 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 Key7398975
MDR Text Key104533265
Report Number1819470-2018-00039
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 04/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9557
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/08/2018
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: 04/05/2018 Patient Sequence Number: 1
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