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

Model Number MS9663

Device Problems Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954)

Patient Problem Hyperglycemia (1905)

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.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This spontaneous case, reported by a consumer to report adverse events, concerned a male patient of unknown age and origin.Medical history was not provided.Concomitant medication included insulin glargine, used for unknown indication.The patient received human insulin (rdna origin) (humulin r) from a cartridge via humapen luxura (champagne), for treatment of type two diabetes mellitus.Information related to dosage regimen and therapy start date was not provided.On an unknown date in (b)(6) 2018, while on human insulin, his humapen luxura was not working correctly and possibly administered irregular dose.As a result, he had high blood glucose and reached up to 12 (no units were provided).He was hospitalized and had insulin via syringe.Information regarding corrective treatment, outcome of events and human insulin therapy status was not provided.The user of the device was patient and his training status was not provided.The device model duration of use and suspect device duration of use of device was approximately one year.The action taken with the suspect device was not provided and its return was not expected.The reporting consumer did not provide relatedness assessment between events and human insulin or humapen luxura.Edit 05apr2018: updated medwatch and (b)(4) fields for expedited device reporting.No new information added.

Manufacturer Narrative

Event: narrative field: new, updated and corrected information is referenced within the update statements in event.Please refer to update statement dated 25apr2018 in the event field.No further follow-up is planned.Evaluation summary: a male patient reported that his humapen luxura device was not working correctly and possibly administered an irregular dose.He experienced increased blood glucose.The device was not returned for investigation (batch: 1207b01, manufactured july 2012).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the batch did not identify any atypical findings with regard to device not working or device 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.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This spontaneous case, reported by a consumer to report adverse events and product complaint (pc), concerned a male patient of unknown age and origin.Medical history was not provided.Concomitant medication included insulin glargine, used for unknown indication.The patient received human insulin (rdna origin) (humulin r) from a cartridge via a reusable humapen luxura (champagne) device, for treatment of type two diabetes mellitus.Information related to dosage regimen and therapy start date was not provided.On an unknown date in feb-2018, while on human insulin, his humapen luxura (champagne) device was not working correctly and possibly administered irregular dose (b)(4) /lot: 12207b01).As a result, he had high blood glucose and reached up to 12 (no units were provided).He was hospitalized and had insulin via syringe.Information regarding corrective treatment, outcome of events, and human insulin therapy status was not provided.The user of the device was patient and his training status was not provided.The device model duration of use and suspect device duration of use of device was approximately one year.The suspect device, which was manufactured in jul2012, was not returned to the manufacturer.The reporting consumer did not provide relatedness assessment between events and human insulin or humapen luxura (champagne) device.Edit 05apr2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 25apr2018: additional information received on 24apr2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Added date of manufacturer for (b)(4) associated with lot: 1207b01 of humapen luxura (champagne) device.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: 7444556
• MDR Text Key: 106007294
• Report Number: 1819470-2018-00053
• 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: 05/18/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9663
• Device Lot Number: 1207B01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization