MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA, BURGUNDY; FOR TREATMENT PURPOSES

Model Number MS9662

Device Problems Failure to Deliver (2338); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted when the final evaluation is completed as necessary.This report is associated with 1819470-2020-00131 and 1819470-2020-00133 since there is more than one device implicated.

Event Description

(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 (b)(6) 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 2004.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 5302983/ batch number unknown, pc 5306096/ 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 5302983, 5306096 and 5302984 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)(eu/(b)(6)) fields and added contact log according for expedited device reporting.No new information added.

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 70 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 2004.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 5302983/ batch number unknown, pc 5306096/ 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 and the stop date was unknown).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.The use of humapen luxura burgundy was ongoing.The suspect devices were not returned to the manufacturer.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 5302983, 5306096 and 5302984 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 canadian (eu/ca) fields and added contact log according for expedited device reporting.No new information added.Update 08oct2020: additional information received on 07oct2020 from the global product complaint database.Entered the device specific safety summary (dsss) and updated the medwatch and european and canadian (eu/ca) device fields for the suspect device associated with pc 5302983 and 5306096.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields; and added date of manufacture for the suspect device associated with pc 5302984.Corresponding fields and narrative updated accordingly.Update 09oct2020: additional information received on 08oct2020 from the global product complaint database.No new information added.

Manufacturer Narrative

B.5.Narrative field; new updated and corrected information is referenced within the update statements in b.5.Please refer to statement dated 08oct2020 in the b.5.Field.No further follow up is planned.This report is associated with 1819470-2020-00131 and 1819470-2020-00133 since there is more than one device implicated.Evaluation summary: a female patient reported that insulin could not be injected from her humapen luxura device.She experienced hypoglycemia.The device was not returned to the manufacturer for investigation (batch number 1111b05, manufactured november 2011).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the device batch did not identify any atypical findings with regard to device not working or dose accuracy issues.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.There is no evidence of improper use or storage.

• Brand Name: HUMAPEN LUXURA, BURGUNDY
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 10615391
• MDR Text Key: 209600541
• Report Number: 1819470-2020-00132
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K142518
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9662
• Device Lot Number: 1111B05
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 10/07/2020
• Supplement Dates FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 70