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

Model Number MS9663

Device Problems Leak/Splash (1354); Defective Device (2588)

Patient Problems Vomiting (2144); Underdose (2542); No Code Available (3191)

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 a consumer, who contacted the company to report adverse events, concerns a male patient of unknown age and ethnicity.Medical history was not reported.Concomitant medication included insulin glargine, used for unknown indication.The patient received insulin lispro (humalog), via reusable device, unknown dose, frequency, route of administration, indication for use and start date.On unknown date in 2011, unknown time after starting the treatment with insulin lispro, the patient experienced pancreatitis, it was reported that this event reoccurred in 2013.The event pancreatitis was considered serious by the company due to medically significant reasons.Information regarding corrective treatment, exams and event outcome was not provided.On unknown date, unknown time after starting the treatment with insulin lispro with humapen luxura champagne, it was reported that the device had a problem, and on unknown date the patient experienced a crisis, reported as diabetes issue, that started with vomiting, and the patient was hospitalized in the intensive care unit (icu) on (b)(6) 2019 due to the reported crisis.As of (b)(6) 2019, the patient was still hospitalized and being submitted to exams to investigate the crisis, which was related to acidosis, and a possible pancreatitis.No exams results were provided.Further, it was explained about the reported problem with humpen luxura champagne that, when they injected the medication, they noticed a smell and it was as if the device was leaking, it wet their hand and they were afraid that the device was not injecting the correct dose of insulin lispro, also reported as they had the impression that the device was defective for a while.This was associated with product complaint number (b)(4), lot number not provided.Corrective treatment and events outcome were not provided.The status of insulin lispro therapy was unknown.It was unknown who operated the device and if the operator was trained.It was unknown for how long the device model had been used, the reported device had been used for approximately four years.The status of device return was unknown.The reporting consumer related the event of crisis (diabetes issue), vomiting, acidosis, possible pancreatitis and not injecting the correct dose to the device.No other relatedness opinion was provided.This case is cross referenced to the following case: (b)(4) (same reporter).Update 08may2019: upon review on 07may2019, it was determined that (b)(4) is a duplicate of this report; therefore, it will be deleted from the database.All information from (b)(4) has been captured in this case.Additional information received on 07may2019 from call center was processed within the initial case entry.Update 10may2019: additional information received on 08may2019 from initial consumer reporter via call center.No new medically significant information was added to the case.Edit 16may2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 22may2019: additional information received on 20may2019 from quality department.Added information regarding product complaint number on narrative.No other change was made to the case.

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 06jun2019 in the b.5.Field.No further follow up is planned.Evaluation summary: the father of a male patient reported that the patient's humapen luxura device was leaking, and they were afraid that the device was not injecting the correct dose of insulin.He experienced diabetic complication.The device was not returned for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer, who contacted the company to report adverse events, concerns a male patient of unknown age and ethnicity.Medical history was not reported.Concomitant medication included insulin glargine, used for unknown indication.The patient received insulin lispro (humalog), via reusable device, unknown dose, frequency, route of administration, indication for use and start date.On unknown date in 2011, unknown time after starting the treatment with insulin lispro, the patient experienced pancreatitis, it was reported that this event reoccurred in 2013.The event pancreatitis was considered serious by the company due to medically significant reasons.Information regarding corrective treatment, exams and event outcome was not provided.On unknown date, unknown time after starting the treatment with insulin lispro with humapen luxura champagne, it was reported that the device had a problem, and on unknown date the patient experienced a crisis, reported as diabetes issue, that started with vomiting, and the patient was hospitalized in the intensive care unit (icu) on (b)(6) 2019 due to the reported crisis.As of (b)(6) 2019, the patient was still hospitalized and being submitted to exams to investigate the crisis, which was related to acidosis, and a possible pancreatitis.No exams results were provided.Further, it was explained about the reported problem with humpen luxura champagne that, when they injected the medication, they noticed a smell and it was as if the device was leaking, it wet their hand and they were afraid that the device was not injecting the correct dose of insulin lispro, also reported as they had the impression that the device was defective for a while.This was associated with product complaint number (b)(4), lot number not provided.Corrective treatment and events outcome were not provided.The status of insulin lispro therapy was unknown.It was unknown who operated the device and if the operator was trained.It was unknown for how long the device model had been used, the reported device had been used for approximately four years.The suspect device was not returned to the manufacturer.The reporting consumer related the event of crisis (diabetes issue), vomiting, acidosis, possible pancreatitis and not injecting the correct dose to the device.No other relatedness opinion was provided.This case is cross referenced to the following case: (b)(4) (same reporter).Update 08may2019: upon review on 07may2019, it was determined that (b)(4) is a duplicate of this report; therefore, it will be deleted from the database.All information from (b)(4) has been captured in this case.Additional information received on 07may2019 from call center was processed within the initial case entry.Update 10may2019: additional information received on 08may2019 from initial consumer reporter via call center.No new medically significant information was added to the case.Edit 16may2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 22may2019: additional information received on 20may2019 from quality department.Added information regarding product complaint number on narrative.No other change was made to the case.Update 06jun2019: additional information received on 03jun2019 from the global product complaint database.Entered the device specific safety summary (dsss).Updated the medwatch and european and canadian (eu/ca) device fields and improper use and storage from yes to no for the suspect device associated with (b)(4).Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN LUXURA CHAMPAGNE
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 8659647
• MDR Text Key: 146816059
• Report Number: 1819470-2019-00096
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9663
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization