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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 Problems Failure to Deliver (2338); Physical Resistance/Sticking (4012)
Patient Problems Headache (1880); Dizziness (2194)
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 spontaneous case, reported by consumer who contacted the company to report adverse events and product complaint (pc), concerned a (b)(6)-years-old male patient of (b)(6) nationality. Medical history (complicating disease, allergic history, family medical history), previous drug adverse reaction and family drug reaction were none. Concomitant medication were not provided. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from cartridge via reusable pen (humapen ergo ii, blue), twice daily (24 units in morning and 14units at night), subcutaneously for the treatment of diabetes mellitus beginning on an unknown date (more than ten years ago at the time of initial report). On an unknown date while on human insulin isophane suspension 70%/human insulin 30% therapy, there was a situation that the injection button could not be pressed on the humapen ergo ii ((b)(4)/ lot number 1510d01) and the needle was changed when one insulin cartridge was changed (improper use). On an unknown date, his fasting blood glucose was high (blood glucose level 19, no units and reference ranges were provided). He also experienced headache and dizziness. On (b)(6) 2019, he was hospitalized due to the events. On (b)(6) 2019, he was discharged. As of (b)(6) 2019, the situation of headache, dizziness and high fasting blood glucose was recovering. Information regarding corrective treatment and laboratory test done during hospitalisation were not provided. Human insulin isophane suspension 70%/human insulin 30% therapy was ongoing. The operator of the humapen ergo ii and his/her training status was not provided. The model humapen ergo ii duration of use and the suspect humapen ergo ii duration of use were not provided. The use of the suspect humapen ergo ii was ongoing and its return was expected. The reporting consumer did not know if the events were related to human insulin isophane suspension 70%/human insulin 30% therapy and did not provide a relatedness assessment for the events to humapen ergo ii. Update 01-nov-2019: pc number was received from the affiliate on 29-oct-2019. Pc was previously processed. Edit 06nov2019: 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 Key9366762
MDR Text Key185090333
Report Number1819470-2019-00201
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 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2019
Is this an Adverse Event Report? Yes
Device Operator Other
Device Model NumberMS9557
Device Lot Number1510D01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2015
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: 11/23/2019 Patient Sequence Number: 1
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