MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN; FOR TREATMENT PURPOSES

Model Number MS9673A

Device Problems Loose or Intermittent Connection (1371); Failure to Deliver (2338)

Patient Problems Fall (1848); Hyperglycemia (1905); Hypoglycemia (1912); Overdose (1988)

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

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint, concerned a (b)(6)-years-old (at the time of initial report) female patient of unknown origin.Medical history was not provided.Concomitant medications included insulin glargine for the treatment of type 1 diabetes.The patient received insulin lispro (rdna origin) (humalog 100 u/ml) from a cartridge via a reusable humapen luxura hd (green color), with unknown dose, on sliding scale subcutaneously, for the treatment of type 1 diabetes, beginning on an unknown date.On an unknown date in (b)(6) 2018, she fell and put a hole in her knee.She needed a new knee.The events of fall and hole in knee were considered as serious by company due to their medically significance.On an unknown date in the past she thought the humapen luxura hd (green color) device was not working so she kept using it to give herself more insulin, she ended up overdosing on insulin and had to take an ambulance to the emergency department (pc# (b)(4), lot# unknown).Her blood sugar was as low as 30.She was given glucose strips and spent 12 hours in the emergency department.During her time in the emergency department her blood sugar was going up and down.The event of blood sugar decreased was considered as serious by company due to its medically significance.Since an unknown date the piece of the screw that touches the plunger was loose.Her blood sugar was going up because no insulin was coming out of the pen.Her pharmacy gave her insulin lispro (humalog u100) kwikpens which resolved her increased blood sugar.She had not had any problems with the insulin lispro u100 kwikpen.Information regarding further corrective treatment was not provided.Outcome of the events hole in knee was not recovered, outcome of the event fall was unknown while outcome of the remaining events was recovered.Status of insulin lispro therapy was unknown.The patient was the operator of the humapen luxura hd (green color) device and her training status was not provided.The general humapen luxura hd (green color) device model duration of use and the suspect device duration of use were not reported.The action taken with suspect humapen luxura hd (green color) device was unknown and its return status was expected.The initial reporting consumer did not consider the events related to insulin lispro drug.The reporting consumer considered that the events of blood sugar increased (both episodes), blood sugar decreased and overdose were related to humapen luxura hd (green color) device, while did not consider the events of fall and hole in knee related to humapen luxura hd (green color) device.Edit 24dec2019: updated medwatch fields for expedited device reporting.No new information added.Edit 02jan2020: the unique device identifier of (b)(4) for the humapen luxura half-dose device was added for expedited device reporting.

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(s) dated 10jan2020 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that, on an unknown date in the past, she thought her humapen luxura hd device was not working so she kept using it to give herself more insulin.She experienced decreased blood glucose.In addition, she reported that the piece of the injection screw that touches the plunger of her humapen luxura hd device was loose.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.The user perception of the injection screw movement accurately represents the device functionality.The foot of the injection screw is designed to be flexible to fully engage with the plunger of the cartridge.The core instructions for use states if any of the parts of your humapen luxura hd device appear broken or damaged, do not use.In addition, the patient gave herself additional doses when she believed the pen did not work correctly.The core instructions for use states "if you do not think you received your full dose, do not take another dose.Call lilly or your healthcare professional for assistance." the patient also reported that the device was stored in the refrigerator.The core instructions for use states to not to store the device in a refrigerator.There is evidence of improper use.The patient continued to use the device after experiencing problems with it and injected additional doses.These misuses may be relevant to the event of decreased blood glucose.The patient stored the device in the refrigerator.This misuse may not be relevant to the event of decreased blood glucose.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint, concerned a 73-years-old (at the time of initial report) female patient of unknown origin.Medical history was not provided.Concomitant medications included insulin glargine for the treatment of type 1 diabetes.The patient received insulin lispro (rdna origin) (humalog 100 u/ml) from a cartridge via a reusable humapen luxura hd (green color), with unknown dose, on sliding scale subcutaneously, for the treatment of type 1 diabetes, beginning on an unknown date.On an unknown date in (b)(6)2018, she fell and put a hole in her knee.She needed a new knee.The events of fall and hole in knee were considered as serious by company due to their medically significance.On an unknown date in the past she thought the humapen luxura hd (green color) device was not working but she kept using it to give herself more insulin, she ended up overdosing on insulin and had to take an ambulance to the emergency department ((b)(4), lot unknown).Her blood sugar was as low as 30.She was given glucose strips and spent 12 hours in the emergency department.During her time in the emergency department her blood sugar was going up and down.The event of blood sugar decreased was considered as serious by company due to its medically significance.Since an unknown date the piece of the screw that touches the plunger was loose.It was also noted that the device was stored in the refrigerator.Her blood sugar was going up because no insulin was coming out of the pen.Her pharmacy gave her insulin lispro (humalog u100) kwikpens which resolved her increased blood sugar.She had not had any problems with the insulin lispro u100 kwikpen.Information regarding further corrective treatment was not provided.Outcome of the events hole in knee was not recovered, outcome of the event fall was unknown while outcome of the remaining events was recovered.Status of insulin lispro therapy was unknown.The patient was the operator of the humapen luxura hd (green color) device and her training status was not provided.The general humapen luxura hd (green color) device model duration of use and the suspect device duration of use were not reported.The action taken with suspect humapen luxura hd (green color) device was unknown and its was not returned to the manufacturer.The initial reporting consumer did not consider the events related to insulin lispro drug.The reporting consumer considered that the events of blood sugar increased (both episodes), blood sugar decreased and overdose were related to humapen luxura hd (green color) device, while did not consider the events of fall and hole in knee related to humapen luxura hd (green color) device.Edit 24dec2019: updated medwatch fields for expedited device reporting.No new information added.Edit 02jan2020: the unique device identifier of (b)(4) for the humapen luxura half-dose device was added for expedited device reporting.Update 10jan2020: additional information received on 10jan2020 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, improper use and storage from no to yes, and device return status to not returned to manufacturer for (b)(4) associated with unknown lot of humapen luxura hd device.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN LUXURA HALF-DOSE PEN
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 9555265
• MDR Text Key: 189350175
• Report Number: 1819470-2019-00229
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• Combination Product (y/n): N
• PMA/PMN Number: K100988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9673A
• Device Catalogue Number: MS9673
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR