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

Model Number MS9673

Device Problem Failure to Deliver (2338)

Patient Problem Test Result (2695)

Event Date 07/30/2017

Event Type  Injury  

Manufacturer Narrative

There was no reported complaint for this device and its return is not expected.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.

Event Description

(b)(4).This report is associated with product compliant: pending.This solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter via psp, concerned a (b)(6) patient of unspecified gender.Medical history was not provided.Concomitant medications included insulin glargine for type 1 diabetes mellitus.The patient received an unspecified form of insulin lispro (rdna origin) injections (humalog) via reusable pen (humapen luxura half-dose) three times daily, for the treatment of type 1 diabetes mellitus, beginning approximately in 2011.Dose and route of administration were not provided.Since unknown date, sometimes the patient was not able to administrate the insulin lispro pen.On (b)(6) 2017, the patient was suffering from decreasing of blood glucose and increasing of blood glucose.When the patient was not able to administrate insulin lispro, the patient was being like falling into coma, the blood glucose was increasing up to 500 (no units).This event was considered serious due to its medical significance.Information regarding corrective treatment was not reported.Outcome of the events was not recovered.Insulin lispro was continued.The patient was the operator of the humapen luxura half-dose and her/his training status was not provided.The humapen luxura half-dose model and suspect humapen luxura half-dose duration of use was of 6 years.The suspect device usage was continuing; its return was not expected.The reporting consumer assessed the events as not related to insulin lispro drug, but related all the events as related to humapen luxura half-dose.Update 25-aug-2017: additional information received from the initial reporter via a psp on 22-aug-2017.Added reusable pen as suspect device.Upon revision of information received on 14-aug-2017 entered missing information: non-serious event of blood glucose increased, laboratory test of blood sugar increased and decreased; changed insulin lispro kwikpen to insulin lispro unknown form; erase kwikpen as suspect device.Updated narrative with new information.Update 19sep2017: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

Manufacturer Narrative

No further follow-up is planned.Evaluation summary: a relative of a patient reported sometimes, the patient was not able to administer the insulin from the humapen luxura hd device.The patient experienced hyperglycemic coma.The device was not returned for investigation (batch number unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen luxura hd devices are assessed for injection screw travel and backdrive force at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.The relative indicated the patient had used the humapen luxura hd device for 6 years.The user manual states the humapen luxura hd device has been designed to be used for up to 3 years after first use.There is evidence of improper use.It is likely the patient used the device beyond its approved use life.It is unknown if this is relevant to the complaint.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter via psp, concerned a (b)(6) years-old caucasian patient of unspecified gender.Medical history was not provided.Concomitant medications included insulin glargine for type 1 diabetes mellitus.The patient received an unspecified form of insulin lispro (rdna origin) injections (humalog) via reusable pen (humapen luxura half-dose) three times daily, for the treatment of type 1 diabetes mellitus, beginning approximately in 2011.Dose and route of administration were not provided.Since unknown date, sometimes the patient was not able to administrate the insulin from the humapen luxura half-dose device; further described, there were difficulties administering the pen (product complaint (b)(4), lot number unknown).On (b)(6) 2017, the patient was suffering from decreasing of blood glucose and increasing of blood glucose.When the patient was not able to administrate insulin lispro, the patient was being like falling into coma, the blood glucose was increasing up to 500 (no units).This event was considered serious due to its medical significance.Information regarding corrective treatment was not reported.Outcome of the events was not recovered.Insulin lispro was continued.The patient was the trained operator of the humapen luxura half-dose device.The humapen luxura half-dose model and suspect humapen luxura half-dose duration of use was of 6 years.The suspect device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer assessed the events as not related to insulin lispro drug, but related all the events as related to the humapen luxura half-dose device.Update 25-aug-2017: additional information received from the initial reporter via a psp on 22-aug-2017.Added reusable pen as suspect device.Upon revision of information received on (b)(6) 2017 entered missing information: non-serious event of blood glucose increased, laboratory test of blood sugar increased and decreased; changed insulin lispro kwikpen to insulin lispro unknown form; erase kwikpen as suspect device.Updated narrative with new information.Update 19sep2017: updated medwatch and european and (b)(6) fields for expedited device reporting.No new information added.Update 20nov2017: additional information received on 20nov2017 from the global product complaint database.Recoded suspect humapen luxura half-dose pen, model ms9673a to humapen luxura half-dose pen, model ms9673 relating to product complaint (b)(4).Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and (b)(6) device information.Added unique identifier number for the suspect humapen luxura half-dose device and noted the device relating to product complaint (b)(4) was not returned to manufacturer.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
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; medical device manufacturing; 415 red cedar street; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 6880974
• MDR Text Key: 86989599
• Report Number: 1819470-2017-00165
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K063151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9673
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12 YR
• Patient Weight: 40