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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 Problem Infarction, Cerebral (1771)
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 compliant: (b)(4). This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerned a (b)(6)-year-old male patient of (b)(6) nationality. Medical history (complicating disease, allergic history, family medical history), previous drug adverse reaction and family drug adverse reaction were none. Concomitant medication included insulin glargine for unknown indication. The patient received insulin lispro (rdna origin) injections (humalog, 100u/ml) from cartridge via reusable pen (humapen ergo ii, reported as green plastic in color), 14units three times a day, subcutaneously, for the treatment of diabetes mellitus from 2012-2013. On an unknown date in (b)(6) 2019, after starting insulin lispro therapy, he experienced cerebral infarction. In (b)(6) 2018, he again had cerebral infarction. Both the episodes of cerebral infarction were considered serious due to medical significance. On an unknown date, he had high blood glucose (no values and reference ranges were provided). On an unknown date, he was hospitalized due to high blood glucose. His humapen ergo ii (green plastic) did not work well and the pen could not push insulin out on (b)(6) 2019 (pc (b)(4)/ lot number 1106d02). Information regarding corrective treatment, outcome for the events and hospitalisation details were not provided. Insulin lispro therapy was ongoing. Follow up was not possible as the reporter refused to be followed up via phone and physician contact details were not provided. The operator of the humapen ergo ii and his/her training status was not provided. The humapen ergo ii model duration of use were not provided. The humapen ergo ii suspect duration of use was seven years as it was started from 2012-2013. The use of the suspect humapen ergo ii was discontinued and its return status was not provided. The reporting consumer did not know if the events were related to insulin lispro therapy and did not provide a relatedness assessment for the events to humapen ergo ii. Update 04-dec-2019: both information received on 02-dec-2019 were processed together. Edit 12dec2019: 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 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 Key9476381
MDR Text Key188591987
Report Number1819470-2019-00224
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 02/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number1106D02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2011
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: 12/16/2019 Patient Sequence Number: 1
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