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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); Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)
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. This report is associated with 1819470-2020-00162, since there is more than one device implicated.
 
Event Description
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) year old female patient of unknown origin. Medical history were not provided. Concomitant medications included gansulin (as reported) for unknown indication. The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) (humalog mix25) via cartridge via humapen ergo ii device (since 2014, conflicting information was provided); subcutaneously 18 units in the morning and 16 units in the evening for the treatment of type one diabetes, beginning from seven or eight years ago (or 2015, conflicting information was provided). On an unknown date in 2018, she did a computerized tomography (ct) examination for spinal pain that was caused by reasons of working. On (b)(6) 2018, she was hospitalized due to the blood glucose was too high (no units, values and ranges were provided), cough, particularly severe oedema, swelling all over the body, severe condition of fluid build-up in the heart (reported as severe hydrops in the heart). On (b)(6) 2018 she was hospitalized due to an unknown reason. In an unknown date she was hospitalized for cold, cough, edema caused by inflammation in the lungs, anemia, hypoalbuminemia and other unspecified reasons. On an unknown date, the pen was not injecting and the button could not be pressed and no liquid would come out (pc number: (b)(4), batch/lot number: unknown). On an unknown date, she was hospitalized for high blood glucose and low blood glucose (no units, values and ranges were provided). Since an unknown date she experienced high blood pressure and high blood sugar (normal reference range and units no were provided). She continued in hospitalization. On an unknown date, the injection pen was not flexible, could not be pushed down (batch lot number: unknown; pc number: (b)(4)). She had used the device for over 6 years. Information regarding hospitalization dates, laboratory examination findings and corrective treatments was not provided. Insulin lispro treatment was continued. The patient was the operator of the suspect humapen ergo ii devices and her training status was not provided. The general device duration of use for the humapen ergo ii devices was not provided. The first humapen ego ii suspect device model duration was started sometime in 2010 and the second humapen ego ii suspect device model duration was sometime in 2014. If suspect devices were returned, evaluation would be performed to determine if a malfunction had occurred. The reporting consumer did not provide an assessment of relatedness between the events with insulin lispro treatment or with the humapen ego ii suspect devices. Update 08-jan-2019: information received from affiliate on 03-jan-2019. Pc number received and already processed in catool. No changes has been made to the case. Update 17-jan-2019: information received from affiliate on 15-jan-2019. The narrative was updated with new information. Update 13-feb-2019: information received from affiliate on 12-feb-2019. No new medically significant information was received and no further changes were made to the case. Edit 12-mar-2019: upon review, batch/lot number filed was updated as it was a mandatory field for argus 8. Update 10-nov-2020: additional information received from the initial consumer reporter on 04-nov-2020. Added lab tests, new suspect humapen ergo ii device, added serious events of blood glucose increased (two), oedema (second event), pericardial effusion, swelling (body), cough (second event) and blood glucose decreased. Updated euca for both the devices and narrative with new information. Edit 11-nov-2020: upon review of information, updated the narrative with correct information regarding pc and onset date of event. No other changes were made to the case. Edit 12nov2020: updated medwatch and european and canadian (eu/ca) fields and added contact log according 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 Contact
chris davis
lilly corporate center
indianapolis, IN 46285
MDR Report Key10837401
MDR Text Key218912312
Report Number1819470-2020-00161
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 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2020
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: 11/13/2020 Patient Sequence Number: 1
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