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

Model Number MS9662

Device Problems Defective Device (2588); Human-Device Interface Problem (2949); Mechanical Jam (2983)

Patient Problems Hyperglycemia (1905); Anxiety (2328); Diabetic Ketoacidosis (2364); Underdose (2542)

Event Date 05/17/2015

Event Type  malfunction  

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a pharmacist who contacted the company to report an adverse event with a product complaint (pc), concerns a (b)(6) light brown male patient.The medical history of patient included only diabetes as believed by reporting pharmacist.The concomitant medication included omeprazole, sertraline, enoxaparin, ipratropium and lorazepam, all of them for unknown indications.Also patient received insulin glargine for diabetes.Patient used insulin glargine on the clickstar device pen.The patient received human insulin nph (rdna origin) and human insulin regular (rdna origin) (both unknown manufacturer), both of unknown formulation via syringe, unknown dose, frequency, route of administration, for treatment of diabetes, beginning on an unknown date.On an unspecified date, unknown time after the starting of human insulin nph and human insulin regular, the patient experienced uncontrolled diabetes.The reporting pharmacist believed that it occurred due to the low treatment compliance of the patient because he had a lot of fear of needles whose onset date was not provided.Information regarding outcome and corrective treatment for fear of needles was not provided.As corrective measure for the uncontrolled diabetes the patient changed his treatment from human insulins to insulin glargine and insulin lispro (humalog) cartridge via humapen luxura burgundy, dose varied in accordance to glycemia measurement, unknown frequency, subcutaneously, approximately in (b)(6) 2014.On an unknown date the patient recovered from the event of uncontrolled diabetes and it was provided that he sometimes did not use insulin because he had few financial conditions to buy the pen needles.On an unspecified date, reported as since the first insulin lispro applications via humapen luxura burgundy (lot number 1401b08; product complaint number (b)(4)), the pen was defective but the patient never contacted the company in order to exchange it.It was provided that the pen was jammed and due to that the patient was not applying insulin correctly.The dose knob of pen did not get down and it turned hard when the application was performed and the patient rotated the dose knob instead of press it during the application.Information regarding outcome and corrective treatment for the incorrect dose administered was not provided.On an unspecified date, unknown time after the starting of insulin lispro via humapen luxura burgundy, the patient had episodes of hyperglycemia and uncontrolled diabetes.The reporting pharmacist believed that it was caused by the bad treatment compliance of patient.On (b)(6) 2015, five months later after insulin lispro commencing, the patient experienced diabetic ketoacidosis and he was hospitalized on the same date as corrective measure.The patient also stayed some days at intensive care unit due to unknown reason.As corrective measure for the event of hyperglycemia the patient was followed at hospital.It was provided that patient had previous hospitalizations but no information was provided regarding his admissions and their reasons.It was provided that the glycemia became controlled when the patient was hospitalized because the insulin applications were performed by nurses and he was trained correctly by them regarding the pen use.Patient remained hospitalized and he was recovering from the event of diabetic ketoacidosis and from the episodes of hyperglycemia.Treatment with insulin lispro was continued and the reporting pharmacist requested a visit of a company representative in order to help the patient.The patient operated the device and he was trained by a nurse.The patient had used the device model and the reported device for approximately six months.The device return was expected and if device is returned, evaluation will be performed to determine if a malfunction has occurred.The reporting pharmacist considered the event of uncontrolled diabetes not related to human insulin nph and human insulin regular but related to the low treatment compliance of patient and did not provide a relatedness opinion between these human insulins and the event of fear of needle.The reporting pharmacist also considered the events of hyperglycemia and diabetic ketoacidosis not related to insulin lispro and stated that the hyperglycemia was related to the bad treatment compliance of patient.A relatedness opinion between insulin lispro and the event of incorrect dose administered was not provided and the reporting pharmacist considered this event related to the humapen luxura burgundy.A relatedness opinion between humapen luxura burgundy and the events of hyperglycemia and diabetic ketoacidosis was not provided.Update 16jun2015: additional information received on 11jun2015 from the reporting pharmacist was processed with initial case.Edit 18jun2015: upon review, rearranged suspect drugs so most suspect product would be primary product for expedited reporting.Edit 22jun2015: upon internal review on 22jun2015 a non-medically significant edit was completed in order to add the product complaint number associated with the humapen luxura burgundy.Update 06-jul-2015: additional information received on 30-jun-2015 via call center follow up, from a new reporter.The new reporter was added on the case and clarify that the insulin glargine had never been used on humapen luxura burgundy.The patient used insulin glargine with clickstar device pen.No medicament significant follow up.Edit 06-jul-2015: upon internal review the follow up of 30-jun-2015 was incorrectly mark as significant on the general tab, actually the information received on 30-jun-2015 was non medicament significant.No regulatory rules should be generated and no submission should be done on regarding this non-med sig information.Update 10jul2015: upon review, this case was opened to update the medwatch fields for regulatory reporting.

Manufacturer Narrative

This is an initial report.A follow-up report will be submitted when the final evaluation is completed.

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements.Please refer to update statement dated 03aug2015.No further follow up is planned.Evaluation summary a pharmacist reported that a male patient's humapen luxura device was jamming and required a high injection force.He experienced diabetic ketoacidosis and hyperglycemia.Investigation of the returned device (batch 1401b08, manufactured january 2014) found excessive resistance while dosing during functional testing.Dose accuracy and glide force testing could not be performed because of the excessive resistance.Additional investigation of the device found damage to the dialing screw threads and evidence of thread skipping on the dial nut housing threads.This type of damage is consistent with excessive force being applied to the dose knob while in the field.The patient continued to use the device even though the patient was aware that the device was not working properly.The user manual states, 'if any of the parts of your humapen luxura appear broken or damaged, do not use'.Additionally, the patient was not properly injecting with the device.While attempting to administer a dose with the device, the patient was turning the injection button instead of pressing it.The user manual provides the appropriate steps for how to inject a dose.It states, 'you must push the injection button straight down for the dose to be delivered' and 'you will not receive your insulin by turning the dose knob.' there is evidence of improper use.The patient applied excessive force to the dose knob which caused damage to the device.Additionally, the patient did not correctly inject with the device and continued to use the device while it was not working properly.This may be relevant to the complaint of diabetic ketoacidosis and hyperglycemia.

Event Description

(b)(4).This spontaneous case, reported by a pharmacist who contacted the company to report an adverse event with a product complaint (pc), concerns a (b)(6)-year-old light brown male patient.The medical history of patient included only diabetes as believed by reporting pharmacist.The concomitant medication included omeprazole, sertraline, enoxaparin, ipratropium and lorazepam, all of them for unknown indications.Also patient received insulin glargine for diabetes.Patient used insulin glargine on the clickstar device pen.The patient received human insulin nph (rdna origin) and human insulin regular (rdna origin) (both unknown manufacturer), both of unknown formulation via syringe, unknown dose, frequency, route of administration, for treatment of diabetes, beginning on an unknown date.On an unspecified date, unknown time after the starting of human insulin nph and human insulin regular, the patient experienced uncontrolled diabetes.The reporting pharmacist believed that it occurred due to the low treatment compliance of the patient because he had a lot of fear of needles whose onset date was not provided.Information regarding outcome and corrective treatment for fear of needles was not provided.As corrective measure for the uncontrolled diabetes the patient changed his treatment from human insulins to insulin glargine and insulin lispro (humalog) cartridge via humapen luxura burgundy, dose varied in accordance to glycemia measurement, unknown frequency, subcutaneously, approximately in (b)(6) 2014.On an unknown date the patient recovered from the event of uncontrolled diabetes and it was provided that he sometimes did not use insulin because he had few financial conditions to buy the pen needles.On an unspecified date, reported as since the first insulin lispro applications via humapen luxura burgundy (lot number 1401b08; (b)(4)), the pen was defective but the patient never contacted the company in order to exchange it.It was provided that the pen was jammed and due to that the patient was not applying insulin correctly.The dose knob of pen did not get down and it turned hard when the application was performed and the patient rotated the dose knob instead of press it during the application.Information regarding outcome and corrective treatment for the incorrect dose administered was not provided.On an unspecified date, unknown time after the starting of insulin lispro via humapen luxura burgundy, the patient had episodes of hyperglycemia and uncontrolled diabetes.The reporting pharmacist believed that it was caused by the bad treatment compliance of patient.On (b)(6) 2015, five months later after insulin lispro commencing, the patient experienced diabetic ketoacidosis and he was hospitalized on the same date as corrective measure.The patient also stayed some days at intensive care unit due to unknown reason.As corrective measure for the event of hyperglycemia the patient was followed at hospital.It was provided that patient had previous hospitalizations but no information was provided regarding his admissions and their reasons.It was provided that the glycemia became controlled when the patient was hospitalized because the insulin applications were performed by nurses and he was trained correctly by them regarding the pen use.Patient remained hospitalized and he was recovering from the event of diabetic ketoacidosis and from the episodes of hyperglycemia.Treatment with insulin lispro was continued and the reporting pharmacist requested a visit of a company representative in order to help the patient.The patient operated the device and he was trained by a nurse.The patient had used the device model and the reported device for approximately six months.The device return was returned on 26jun2015.The reporting pharmacist considered the event of uncontrolled diabetes not related to human insulin nph and human insulin regular but related to the low treatment compliance of patient and did not provide a relatedness opinion between these human insulins and the event of fear of needle.The reporting pharmacist also considered the events of hyperglycemia and diabetic ketoacidosis not related to insulin lispro and stated that the hyperglycemia was related to the bad treatment compliance of patient.A relatedness opinion between insulin lispro and the event of incorrect dose administered was not provided and the reporting pharmacist considered this event related to the humapen luxura burgundy.A relatedness opinion between humapen luxura burgundy and the events of hyperglycemia and diabetic ketoacidosis was not provided.Update 16jun2015: additional information received on 11jun2015 from the reporting pharmacist was processed with initial case.Edit 18jun2015: upon review, rearranged suspect drugs so most suspect product would be primary product for expedited reporting.Edit 22jun2015: upon internal review on 22jun2015 a non-medically significant edit was completed in order to add the product complaint number associated with the humapen luxura burgundy.Update 06-jul-2015: additional information received on 30-jun-2015 via call center follow up, from a new reporter.The new reporter was added on the case and clarify that the insulin glargine had never been used on humapen luxura burgundy.The patient used insulin glargine with clickstar device pen.No medicament significant follow up.Edit 06-jul-2015: upon internal review the follow up of 30-jun-2015 was incorrectly mark as significant on the general tab, actually the information received on 30-jun-2015 was non medicament significant.No regulatory rules should be generated and no submission should be done on regarding this non-med sig information.Update 10jul2015: upon review, this case was opened to update the medwatch fields for regulatory reporting.Update 24-jul-2015: additional information was received from the call center on 22-jul-2015.It was just provided the tr number of a new complaint record created for the humalog cartridge ((b)(4)).The tr was checked and processed into the catool.No med sig information was added to the case.Update 03aug2016: additional information received on 03aug2015 from the global product complaint database added the device specific safety summary, manufactured date, and returned dated of the device; updated the malfunction field to yes/not cirm; updated the eu/ca and medwatch fields; and updated the narrative.

• Brand Name: HUMAPEN LUXURA BURGUNDY
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-ORIGEN; medical device manufacturing; 415 red cedar street; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 4906129
• MDR Text Key: 6831921
• Report Number: 1819470-2015-00072
• Device Sequence Number: 1
• Product Code: NSC
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K142518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,consumer,foreign,hea
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/10/2015

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: MS9662
• Device Lot Number: 1401B08
• Other Device ID Number: 3360869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2014
• 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
• Treatment: OMEPRAZOLE; SERTRALINE; ENOXAPARIN; IPRATROPIUM; LORAZEPAM; LANTUS; HUMULIN
• Patient Outcome(s): Hospitalization
• Patient Age: 39 YR
• Patient Weight: 46