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

Model Number MS9662

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hyperglycemia (1905)

Event Date 05/31/2018

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)(6).This report is associated with product complaint: pending.This spontaneous case, reported by a consumer concerned a patient of unknown age and an unspecified origin.Medical history included hypertension, hyperlipidemia, and heart stenting, and the previous drug adverse reaction was none, and family drug reaction was none and concomitant medications included hypotensive drugs and drug for heart disease.The patient received human insulin isophane suspension (rdna origin) (humulin n 100units/ml,) via cartridge subcutaneously 10 units daily mellitus from an unknown date.The patient also received insulin lispro (humalog, 100units/ml via cartridge) at a dose of 18 units in morning, 18 units in noon, and 18 units in night subcutaneously for the treatment of diabetes mellitus from unknown date.Patient also used an unknown humapen device, from (b)(6) 2018.On an unspecified date in (b)(6) 2018, after starting human insulin isophane suspension and insulin lispro patient experienced high blood glucose in the morning and the pre-prandial blood glucose was around 13-14, postprandial blood glucose was around 20-21 ( unit and reference range was not provided) and was hospitalized.Information regarding corrective treatment and other hospital details were not provided.The outcome of the event was unknown.The status of human insulin isophane suspension and insulin lispro was continued.The user of the unknown humapen device, and his\her training status was not provided.The unknown humapen device model duration of use and suspect device duration of use was not reported.The action taken with the suspect device was not provided and its return was not expected.The reporting consumer did not know about relatedness of the event and human insulin isophane suspension and insulin lispro therapy and not provided with unknown humapen device.Edit 15jun2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 18-jun-2018: upon review of information received on (b)(6) 2018, updated the suspect reusable device from humapen luxura burgundy to unknown humapen device and narrative was updated accordingly.No other changes were made in 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 update statement dated 30jul2018 in the b.5.Field.No further follow-up is planned.This is a downgrade report, which no longer meets the criteria for expedited reporting.Evaluation summary: a patient reported that the injection button of their humapen luxura device could not be pushed down.The patient experienced increased blood glucose.Investigation of the returned device (batch 0904b03, manufactured april 2009) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.There is no evidence of improper use and storage.

Event Description

Lilly case id:(b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer concerned a patient of unknown age and an unspecified origin.Medical history included hypertension, hyperlipidemia, and heart stenting, and the previous drug adverse reaction was none, and family drug reaction was none.Concomitant medications included unspecified hypotensive drugs and drug for heart disease.The patient received human insulin isophane suspension (rdna origin) (humulin n 100units/ml,) via cartridge subcutaneously 10 units daily mellitus from an unknown date.The patient also received insulin lispro (humalog, 100units/ml via cartridge) at a dose of 18 units in morning, 18 units in noon, and 18 units in night subcutaneously for the treatment of diabetes mellitus from unknown date.Patient injected via a reusable humapen luxura (burgundy) device.On an unspecified date in may-2018, after starting human insulin isophane suspension and insulin lispro, the patient experienced high blood glucose in the morning explained as pre-prandial blood glucose around 13-14 and postprandial blood glucose around 20-21 (units and reference ranges were not provided).The patient was hospitalized.It was also explained that the injection button could not be pushed down on (b)(6) 2018 (product complaint (b)(4)./lot 0304b03).Information regarding corrective treatment and other hospital details were not provided.The outcome of the event was unknown.The status of human insulin isophane suspension and insulin lispro was continued.The user of the humapen luxura (burgundy) device, and his\her training status was not provided.The humapen luxura (burgundy) device model duration of use and suspect device duration of use was not reported.The suspect device with (b)(4).Which was manufactured in apr2009, was returned to the manufacturer on 13jun2018.The reporting consumer did not know about relatedness of the event to the human insulin isophane suspension and insulin lispro therapy and device relatedness was not provided.Edit 15jun2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 18-jun-2018: upon review of information received on 07-jun-2018, updated the suspect reusable device from humapen luxura burgundy to unknown humapen device and narrative was updated accordingly.No other changes were made in the case.Update 30jul2018: additional information received on 26jul2018 from the global product complaint database.Recoded the device from humapen (unknown) to a humapen luxura (burgundy) device.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information, malfunction from unknown to no, and device return status to returned to manufacturer.Added date of manufacturer, date returned to manufacturer for (b)(4).Associated with lot 0304b03 of a humapen luxura (burgundy) device.Corresponding fields and narrative updated accordingly.

• Brand Name: HP LUXURA, BURGUNDY
• Type of Device: NSC FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 7644970
• MDR Text Key: 112595303
• Report Number: 1819470-2018-00105
• 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: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• 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: 0904B03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization