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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 Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem 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 1819470-2020-00131 and 1819470-2020-00132 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 spontaneous case, reported by consumers via company representative to report adverse events and product complaints (pc), concerned a (b)(6) years old female patient of han nationality. Medical history (complicating disease, allergic history, family medical history) included not good trachea and not good pulmonary function. Previous drug adverse reaction and family drug reaction was none. Concomitant medication included metformin and acarbose for diabetes mellitus. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30) from cartridge via reusable pen (humapen ergo ii and humapen luxura burgundy), twice daily (20 units in morning and 8 units at night), subcutaneously, for the treatment of diabetes mellitus, from (b)(6). On an unknown date, after starting human insulin isophane suspension 70%/human insulin 30% therapy, her eyes were not good. She experienced several times nocturnal hypoglycemia (blood glucose value was 3-4, no units and reference ranges were provided). She had been hospitalized several times due to nocturnal hypoglycemia (how many specific times she had been hospitalized, the time of hospitalization and the time of discharge were not provided). On an unknown date, she had issues with the first and second humapen ergo ii devices (pc (b)(4)/ batch number unknown, pc (b)(4)/ batch number unknown) and they were replaced with the new devices. Then, she had issue with humapen luxura burgundy device that human insulin isophane suspension 70%/human insulin 30% could not be ejected out from the humapen luxura burgundy (pc 5302984/ batch number 1111b05). As of 23-sep-2020, she was not recovering from the events. Information regarding corrective treatment was not provided. Human insulin isophane suspension 70%/human insulin 30% therapy was ongoing. The operator of the devices (both humapen ergo ii devices and humapen luxura burgundy) and his/her training status were not provided. The humapen ergo ii device model duration of use was not provided (it was started in 2004). The first suspect humapen ergo ii device duration of use was not provided (it was started in 2004). The second suspect humapen ergo ii device duration of use was not provided. The humapen luxura burgundy device model duration of use and suspect humapen luxura burgundy device duration of use were not provided. The use of the first and second suspect humapen ergo ii devices was discontinued and their return status was not provided. The use of humapen luxura burgundy was ongoing and its return status was not provided. The reporting consumer did not provide a relatedness assessment for the events to the human insulin isophane suspension 70%/human insulin 30% therapy or both the suspect humapen ergo ii devices or the suspect humapen luxura burgundy device. The reporting consumer related the events to underlying disease condition of diabetes. Update 01-oct-2020: information was received from pc team on 28-sep-2020. Pc number (b)(4) were provided for humapen ergo ii (both batch number were unknown) and humapen luxura burgundy respectively. Reported pcs were already processed in the case. No new medially significant information was received and hence no changes were made to the case. Edit 01oct2020: updated medwatch and european and (b)(6) 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
3174334585
MDR Report Key10615390
MDR Text Key210689100
Report Number1819470-2020-00133
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 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
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: 10/01/2020 Patient Sequence Number: 1
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