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

Model Number MS9662

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Hypoglycemia (1912); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Since the device is not being returned, evaluation for a malfunction is not possible.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, with additional information from initial reporter, concerned a (b)(6) male patient.Medical history included blood pressure was low, diabetes family history and lethargic slept for 6 hours after the injections of sulfadiazine sodium.Concomitant medications included acarbose and tamsulosin hydrochloride, both for unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro (rdna origin) injection (humalog 25) from cartridge via reusable pen (humapen luxura), at 18 iu twice daily subcutaneous for the treatment of diabetes mellitus beginning in 2014.On unknown date his dosage regimen was changed to 20 iu twice daily under the suggestion of physician.On unknown date while on insulin lispro 75/25, he experienced blood glucose decreased (no values provided); due to this, patient changed the dosage regimen to 11 to 12 twice daily gradually.In (b)(6) 2015, he stated that the foot of the injection screw could not touch the plunger.He added a petroleum based gel to the injection screw, and the situation improved.In (b)(6) 2016, only two or three months after the new dosage regimen, he had sweating and other hypoglycemic symptoms and condition of prostate pain (no cause for prostatic pain provided); he was hospitalized due to the events.During the hospitalization, his blood pressure was high (no values provided).Insulin lispro 75/25 was replaced with insulin human (rdna origin) injections (humulin r) from cartridge via reusable pen (humapen luxura) at 16 iu twice daily subcutaneously for the treatment of diabetes mellitus beginning in (b)(6) 2016.On unknown date the dosage regimen changed to 18 iu twice daily, and then was changed again to 20 iu twice daily.In (b)(6) 2016 he was discharged of the hospital.On unknown date with the new dosage regimen, he did not had effect after taking human insulin (lot number c342061a, pc 3878803), so he replaced with insulin lispro 75/25 with a dosage regimen of 24 iu twice daily.In jan2017, he again reported that the device issue where the foot of the injection screw of the humapen luxura burgundy could not touch the plunger had worsened ((b)(4)/lot 1112801).By (b)(6) 2017, he was recovered from prostatic pain and blood pressure increased.Information regarding the outcome of the rest of the events and corrective treatment was not provided.Insulin lispro 75/25 and human insulin treatments status were unknown.The operator of the humapen luxura was the patient and his training status was unknown.The general device duration of use and the reported device use of duration were three years.The humapen luxura usage was continued and the action taken was unknown.The reporting consumer did not know if the events of blood glucose decreased, hypoglycemia, prostatic pain and hypertension were related to insulin lispro 75/25 and related the event of lack of drug effect to human insulin.Update 29jan2017: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting.The description of the product complaint was added to the narrative.Update 24-jan-2017: additional information received from the initial reporter via a psp on 20-jan-2016.Added concomitant medication of tamsulosin hydrochloride; and prostatic pain cause not provided information.Updated suspect device was from humapen unknown device to humapen luxura burgundy; outcome for the events of prostatic pain and hypertension from unknown to recovered; and (b)(4).Upon review, one lab data of blood pressure high and another for normal were added.Updated narrative with new information.Update 01feb2017: upon review, the case was opened to add the product complaint description with dates to the narrative, and update the improper use and storage to yes.

Manufacturer Narrative

No further follow up is planned.Evaluation summary: a male patient reported that injection button on his humapen luxura device could not be pushed down.He also reported that the foot on the injection screw could not touch the plunger in the cartridge, so he applied a petroleum based gel to the injection screw and the situation improved.He experienced hypoglycemia, although, the report of hypoglycemia is inconsistent with the alleged malfunction of insulin not being delivered.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 devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring pen functionality with high probability.The instructions for use state, "do not use alcohol, hydrogen peroxide, or bleach on the pen body or dose window.Also, do not cover in liquid or apply lubrication such as oil, as this could damage the pen." there is evidence of improper use.The patient applied a petroleum based gel to the device, although it is unknown if this relevant to the event of hypoglycemia.

Event Description

(b)(4).This spontaneous case reported by a consumer who contacted the company to report adverse events, with additional information from initial reporter, concerned a (b)(6) male patient.Medical history included blood pressure was low, diabetes family history and lethargic slept for 6 hours after the injections of sulfadiazine sodium.Concomitant medications included acarbose and tamsulosin hydrochloride, both for unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro (rdna origin) injection (humalog 25) from cartridge via reusable pen (humapen luxura), at 18 iu twice daily subcutaneous for the treatment of diabetes mellitus beginning in 2014.On unknown date his dosage regimen was changed to 20 iu twice daily under the suggestion of physician.On unknown date while on insulin lispro 75/25, he experienced blood glucose decreased (no values provided); due to this, patient changed the dosage regimen to 11 to 12 twice daily gradually.In (b)(6) 2015, he stated that the foot of the injection screw could not touch the plunger.He added a petroleum based gel to the injection screw, and the situation improved.In (b)(6) 2016, only two or three months after the new dosage regimen, he had sweating and other hypoglycemic symptoms and condition of prostate pain (no cause for prostatic pain provided); he was hospitalized due to the events.During the hospitalization, his blood pressure was high (no values provided).Insulin lispro 75/25 was replaced with insulin human (rdna origin) injections (humulin r) from cartridge via reusable pen (humapen luxura) at 16 iu twice daily subcutaneously for the treatment of diabetes mellitus beginning in (b)(6) 2016.On unknown date the dosage regimen changed to 18 iu twice daily, and then was changed again to 20 iu twice daily.In (b)(6) 2016 he was discharged of the hospital.On unknown date with the new dosage regimen, he did not had effect after taking human insulin (lot number c342061a, pc (b)(4)), so he replaced with insulin lispro 75/25 with a dosage regimen of 24 iu twice daily.In (b)(6) 2017, he again reported that the device issue where the foot of the injection screw of the humapen luxura burgundy could not touch the plunger had worsened (product complaint (b)(4)/lot 1112801).By (b)(6) 2017, he was recovered from prostatic pain and blood pressure increased.Information regarding the outcome of the rest of the events and corrective treatment was not provided.Insulin lispro 75/25 and human insulin treatments status were unknown.The operator of the humapen luxura was the patient and his training status was unknown.The general device duration of use and the reported device use of duration were three years.The humapen luxura was not returned.The reporting consumer did not know if the events of blood glucose decreased, hypoglycemia, prostatic pain and hypertension were related to insulin lispro 75/25 and related the event of lack of drug effect to human insulin.Update 29jan2017: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting.The description of the product complaint was added to the narrative.Update 24-jan-2017: additional information received from the initial reporter via a psp on 20-jan-2016.Added concomitant medication of tamsulosin hydrochloride; and prostatic pain cause not provided information.Updated suspect device was from humapen unknown device to humapen luxura burgundy; outcome for the events of prostatic pain and hypertension from unknown to recovered; and pc numbers (b)(4).Upon review, one lab data of blood pressure high and another for normal were added.Updated narrative with new information.Update 01feb2017: upon review, the case was opened to add the product complaint description with dates to the narrative, and update the improper use and storage to yes.Update 08-feb-2017: pc received on 16-jan-2017 was determined to be duplicated.No changes were performed to the case.Edit 08-feb-2017: upon review updated routing comment.No further changes were performed.Update 09feb2017: additional information received on 08feb2017 from the global product complaint database added the device specific safety summary; added the device was not returned; updated the medwatch and european and canadian required device reporting elements; 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-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: 6300089
• MDR Text Key: 66472443
• Report Number: 1819470-2017-00014
• 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: 02/24/2017

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: 1112801
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 02/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2017
• 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
• Treatment: GLUCOBAY; HUMALOG; HUMULIN; TAMSULOSIN HYDROCHLORIDE
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 80