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

Model Number MS9662

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 01/31/2015

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.This report is associated with 1819470-2018-00106 since there is more than one device implicated.The humapen luxura (burgundy) device was associated with an abnormal unstable blood sugar on an unknown date in 2015 and the humapen (unknown body type) device was associated with an unstable blood glucose ion an unknown date in (b)(6) 2018.

Event Description

(b)(4).This report is associated with product complaint: pending this spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint, concerned a (b)(6) asian female patient of han nationality.Medical history included fundus hemorrhage.Concomitant medication was not provided.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix 50) via 3 ml: 300 units/cartridge via unknown humapen at a dose of 14 units in the morning and 12 units in the night (bid) subcutaneously for the treatment of diabetes mellitus beginning on sometimes in 2015.On an unknown date in 2015, after started on insulin lispro protamine suspension 50%/insulin lispro 50% therapy, she was hospitalized due to the event of unstable blood glucose.Approximately in (b)(6) 2018, she could not inject in while injection and the patient was admitted to the hospital due to the event of unstable blood glucose ((b)(4); lot 1112b05 and (b)(4); lot unknown).Corrective treatment was not provided.Outcome of the events was unknown.Status of insulin lispro protamine suspension 50%/insulin lispro 50% was continued.The operator of the device unknown humapen and hp luxura pen was patient and her training status was not provided.The unknown humapen model duration of use was not provided but it started on sometime in 2015.The reported unknown humapen duration of use was not provided.The action taken with the unknown humapen and its return status were not provided.The hp luxura model duration of use was not provided but it started in 2010.The reported hp luxura pen duration of use was not provided.The action taken with the hp luxura pen and its return status were not provided.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 50%/insulin lispro 50% therapy or unknown humapen and hp luxura pen.Edit 14jun2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 14jun2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 15-jun-2018: upon internal review for the information received 12-jun-2018.Changed suspect device coding from humapen ergo to unknown humapen.Added device causality as device nhcp for the event of ddo on hp luxura device.Updated narrative with pc number.Edit 21jun2018: updated medwatch and european and canadian (eu/ca) fields 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 a consumer who contacted the company to report adverse events and product complaint, concerned a 52-year-old asian female patient of han nationality.Medical history included fundus hemorrhage.Concomitant medication was not provided.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix 50) via 3ml: 300units/cartridge via an unknown humapen and a humapen luxura burgundy at a dose of 14 units in the morning and 12 units in the night (bid) subcutaneously for the treatment of diabetes mellitus beginning on sometimes in 2015.On an unknown date in 2015, after started on insulin lispro protamine suspension 50%/insulin lispro 50% therapy, she was hospitalized due to the event of unstable blood glucose.Approximately in mar-2018, she could not inject in while injection (b)(4).Lot 1112b05 and (b)(4).Lot unknown) and the patient was admitted to the hospital due to the event of unstable blood glucose.Corrective treatment was not provided.Outcome of the events was unknown.Status of insulin lispro protamine suspension 50%/insulin lispro 50% was continued.The operator of the unknown humapen and hp luxura pen was the patient and her training status was not provided.The unknown humapen model duration of use was not provided.The hp luxura model duration of use was not provided.Both suspect devices were not returned to the manufacturer.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 50%/insulin lispro 50% therapy or unknown humapen and hp luxura pen.Edit 14jun2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 14jun2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 15-jun-2018: upon internal review for the information received 12-jun-2018.Changed suspect device coding from humapen ergo to unknown humapen.Added device causality as device nhcp for the event of drug dose omission on hp luxura device.Updated narrative with pc number.Edit 21jun2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 21jun2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 22-jun-2018: updated abbreviations of the event drug dose omission in narrative.No new information added to the case.Update 03jul2018: additional information received on 03jul2018 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 (b)(4).Entered the device specific safety summary (dsss), updated the medwatch and european and canadian (eu/ca) device fields, and added the date of manufacturer for the suspect device associated with (b)(4).Corresponding fields and narrative updated accordingly.Edit 23jul2018: updated medwatch fields for expedited device reporting.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 03jul2018 in the b.5.Field.No further follow up is planned.This report is associated with 1819470-2018-00106 since there is more than one device implicated.The humapen luxura (burgundy) device was associated with an abnormal unstable blood sugar on an unknown date in 2015 and an unstable blood glucose on an unknown date in jun2018.Evaluation summary: a patient reported the injection button of her humapen luxura device fell off.The device was not returned for investigation (batch 1112b05, manufactured december 2011).Therefore, the device could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of this batch did not identify any atypical trends with regard to detached injection buttons.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.

• Brand Name: HP LUXURA, BURGUNDY
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 7638560
• MDR Text Key: 112377998
• Report Number: 1819470-2018-00107
• 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: 07/31/2018

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9662
• Device Lot Number: 1112B05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 07/03/2018
• Supplement Dates FDA Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Weight: 62