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 Problem Hypoglycemia (1912)

Event Date 05/31/2015

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 solicited case, reported by a consumer via a patient support program (psp), concerns a (b)(6) female patient of unknown specific age (born on (b)(6)) at the onset of the event.Medical history included coronary heart disease, high uric acid, hypertension and hysterectomy.Neither the patient nor her family had experienced a drug adverse reaction.Concomitant medications included metformin, acarbose, glyceryl trinitrate, sodium bicarbonate, a drug reported as wanlishuang and rosuvastatin; all of them for unknown indication.The patient received human insulin (rdna origin) (humulin r) from a cartridge, via a reusable pen (humapen luxura, unknown body type), subcutaneously (dosage regimen unknown), for the treatment of diabetes mellitus, beginning in 2007.On an unspecified date, her blood glucose control was not good and she was switched to insulin lispro (rdna origin) (humalog) from a cartridge, via the humapen luxura device, 18 units (u) at morning and 18 u at night, subcutaneously, for the same indication.The outcome for the event after changing the medication was not reported.In (b)(6)-2015, she had a problem with her humapen luxura.In (b)(6)-2015 (time to onset unknown), while on insulin lispro, she was admitted to the hospital due to hypoglycemia and unstable blood glucose.While in hospital, she was switched to a new cartridge and dose was adjusted to: 12 u in the morning, 10 u at noon and 12 u at night.Further details about her hospital stay were not reported.At the time of this report ((b)(6)-2015), approximately six months after starting the new cartridge and dosage adjustment, her fasting blood glucose was 7 (no units or reference reported) and her postprandial blood glucose (two hours after meal) was 2-3 (no units or reference reported).The treatment with insulin lispro delivered by the humapen luxura was ongoing.Information regarding the operator of the humapen luxura and training status was not provided.The general humapen luxura use started in 2007.The suspect humapen luxura duration of use was unknown.If device is returned, evaluation will be performed to determine if a malfunction has occurred.The initial reporting consumer did not know whether the events were related to the treatment with human insulin and the humapen luxura.Additionally, the initial reporter did not know whether the events were related to the treatment with insulin lispro and the humapen luxura.Update 20nov2015: upon review of this case, the case was opened to update the medwatch fields for regulatory reporting.

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.Narrative field - new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 01dec2015.No further follow up is planned.Evaluation summary a female patient reported that the injection button of her humapen luxura device was difficult to push down.She experienced hypoglycemia and abnormal blood glucose levels.The device was not returned to the manufacturer for investigation (batch 1111b05, manufactured november 2011).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 dose accuracy.A complaint history review of this batch did not identify any atypical trends with regard to dose accuracy or high injection force.There is evidence of improper use.The patient reused needles.This may be relevant to the complaint of difficulty pushing the injection button, but may not be relevant to hypoglycemia.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerns a han chinese female patient of unknown specific age ((b)(6)) at the onset of the event.Medical history included coronary heart disease, high uric acid, hypertension and hysterectomy.Neither the patient nor her family had experienced a drug adverse reaction.Concomitant medications included metformin, acarbose, glyceryl trinitrate, sodium bicarbonate, a drug reported as wanlishuang and rosuvastatin; all of them for unknown indication.The patient received human insulin (rdna origin) (humulin r) from a cartridge, via a reusable pen (humapen luxura, burgundy body), subcutaneously (dosage regimen unknown), for the treatment of diabetes mellitus, beginning in 2007.On an unspecified date, her blood glucose control was not good and she was switched to insulin lispro (rdna origin) (humalog) from a cartridge, via the humapen luxura device, 18 units (u) at morning and 18 u at night, subcutaneously, for the same indication.The outcome for the event after changing the medication was not reported.In (b)(6)-2015, she had a problem with her humapen luxura ((b)(4), lot number 1111b05).In (b)(6)-2015 (time to onset unknown), while on insulin lispro, she was admitted to the hospital due to hypoglycemia and unstable blood glucose.While in hospital, she was switched to a new cartridge and dose was adjusted to: 12 u in the morning, 10 u at noon and 12 u at night.Further details about her hospital stay were not reported.At the time of this report ((b)(6)-2015), approximately six months after starting the new cartridge and dosage adjustment, her fasting blood glucose was 7 (no units or reference reported) and her postprandial blood glucose (two hours after meal) was 2-3 (no units or reference reported).The treatment with insulin lispro delivered by the humapen luxura was ongoing.Information regarding the operator of the humapen luxura and training status was not provided.The general humapen luxura use started in 2007.The suspect humapen luxura duration of use was unknown.The device was not returned.The initial reporting consumer did not know whether the events were related to the treatment with human insulin and the humapen luxura.Additionally, the initial reporter did not know whether the events were related to the treatment with insulin lispro and the humapen luxura.Update 20nov2015: upon review of this case, the case was opened to update the medwatch fields for regulatory reporting.Update 25-nov-2015: pc number was received on 13-nov-2015.Added: pc number to narrative, no additional changes were done to the case.Update 01dec2015: additional information received on 01dec2015 from the global product complaint database added the device specific safety summary and return date of the device; updated the humapen luxura, unknown body type to a humapen luxura, burgundy body based on the verification of the lot number; added the device was not returned; updated the improper use and storage to yes; updated the medwatch and (b)(6) 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: 5238547
• MDR Text Key: 31691197
• Report Number: 1819470-2015-00110
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 11/03/2015

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: Other
• Device Model Number: MS9662
• Device Lot Number: 1111B05
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2011
• 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: ACARBOSE
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 63