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

Model Number MS9663

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Deliver (2338)

Patient Problems Stroke/CVA (1770); Hyperglycemia (1905); Neurological Deficit/Dysfunction (1982); Dysphasia (2195); Underdose (2542)

Event Type  malfunction  

Manufacturer Narrative

Reportable malfunction/incident identified.Investigation in progress.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 two consumers, who contacted the company to report product complaint from a patient who takes part of patient support program, concerns a male patient of unknown ethnicity and age.The medical history included accident cerebrovascular in 1995 and (b)(6) 2013.According to reporter, the patient had small accident cerebrovascular during these last years.The concomitant medication included acetylsalicylic acid with unknown indication for use, allopurinol for uric acid, digoxin for heart, furosemide as diuretic, carvedilol with unknown indication for use, enalapril for pressure, spironolactone as diuretic, clopidogrel bisulfate with unknown indication for use, simvastatin with unknown indication for use and rosuvastatin with unknown indication for use.The patient received human insulin (rdna origin) nph (humulin n), 10iu at night, human insulin (rdna origin) 30%regular + 70%nph (humulin 70/30) 20iu in the morning, human insulin (rdna origin) regular (humulin r) as needed when the blood glucose is 200 (unit not provided) 2iu, when blood glucose is 250 4iu, above 600 6iu reported the maximum dosage is 8iu, all indicated for diabetes, subcutaneously, beginning in 2012.The human insulin 30%regular + 70%nph was delivered with humapen luxura champagne (batch number 1202b05), and human insulin nph and human insulin regular were delivered via humapen unknown device.In (b)(6) 2015, approximately three years after starting human insulin nph, human insulin 30%regular +70%nph and human insulin regular, the patient experienced accident cerebrovascular, and his movement was worse, including locomotion and the arms were fallen and difficult speech.The events accident cerebrovascular, movement was worse and difficult speech were considered serious by the company due to medically significant reasons.The patient did not receive corrective treatment and he did not recover from events.On unspecified date, unknown time after starting human insulin nph, human insulin 30%regular +70%nph and human insulin regular, the patient experienced sleep disorder.As corrective treatment the patient received clonazepam.The patient did not recover from event.In initial of (b)(6) 2015, reported as two week ago from initial report, the humapen luxura champagne which the patient administered human insulin 30%regular +70%nph was not releasing the drug.It was reported that the needle was reused, changing once a week, the patient received the human insulin only in abdomen.Therefore, the operator took the humapen (unknown device) which the patient delivered human insulin regular, and replaced the cartridge to deliver human insulin 30%regular +70%nph.But the operator did not perform prime, and the injection screw did not touch the cartridge plunger.Therefore, the patient did not receive the dose.The patient did not receive corrective treatment, but he recovered from event.On (b)(6) 2016, the humapen luxura champagne was returned and found to have a barrel misalignment.This device was not associated with an adverse event.The human insulin nph, human insulin 30%regular +70%nph and human insulin regular were continued.The consumer is the operator of device, and she is a trained user.It was unknown how long the device models were used, and it was unknown how long the reported device was used.The status of the device associated with product complaint (b)(4) was not provided.The device associated with product complaint (b)(4) was returned on 26-nov-2015.The reporting consumers did not provide opinion of relatedness.On 14dec2015: additional information received on 04dec2015 from the second reporter consumer.No medically significant information was provided.Update 22-dec-2015: additional information received on 22-dec-2015 from the global product complaint database added the return date of the device of (b)(6) 2015 associated with product complaint (b)(4); updated this device to suspect; updated the malfunction field to yes/cirm; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.

Manufacturer Narrative

Evaluation summary the daughter of a male patient reported that the dose knob on her father's humapen luxura device was hard to turn.The device was not associated with an adverse event.Investigation of the returned device (batch (b)(4), manufactured february 2012) found a misalignment of the barrel and damage to the dialing screw threads.The damage was consistent with excessive torque being applied by the user which resulted in the device being dialed beyond the maximum dose setting of 60 units.Evidence of the excessive torque was observed by the wear and damage to the dialing screw threads and also indicated that the dial had been detached by excessive force.The investigation determined that the damage was not associated with the assembly of the device.There is evidence of improper use.The user applied excessive force which caused the damage and misalignment of the device.The user also reused needles and sporadically primed the device, but this was not relevant to the damage.

Event Description

(b)(4) this solicited case, reported by two consumers, who contacted the company to report product complaint from a patient who takes part of patient support program, concerns a male patient of unknown ethnicity and age.The medical history included accident cerebrovascular in 1995 and (b)(6) 2013.According to reporter, the patient had small accident cerebrovascular during these last years.The concomitant medication included acetylsalicylic acid with unknown indication for use, allopurinol for uric acid, digoxin for heart, furosemide as diuretic, carvedilol with unknown indication for use, enalapril for pressure, spironolactone as diuretic, clopidogrel bisulfate with unknown indication for use, simvastatin with unknown indication for use and rosuvastatin with unknown indication for use.The patient received human insulin (rdna origin) nph (humulin n), 10iu at night, human insulin (rdna origin) 30%regular + 70%nph (humulin 70/30) 20iu in the morning, human insulin (rdna origin) regular (humulin r) as needed when the blood glucose is 200(unit not provided) 2iu, when blood glucose is 250 4iu, above 600 6iu reported the maximum dosage is 8iu, all indicated for diabetes, subcutaneously, beginning in 2012.The human insulin 30%regular + 70%nph was delivered with humapen luxura champagne (batch number (b)(4)), and human insulin nph and human insulin regular were delivered via humapen unknown device.In (b)(6) 2015, approximately three years after starting human insulin nph, human insulin 30%regular +70%nph and human insulin regular, the patient experienced accident cerebrovascular, and his movement was worsen, including locomotion and the arms were fallen and difficult to speech.The events accident cerebrovascular, movement was worsen and difficulty speech were considered serious by the company due to medically significant reasons.The patient did not receive corrective treatment and he did not recover from events.On unspecified date, unknown time after starting human insulin nph, human insulin 30%regular +70%nph and human insulin regular, the patient experienced sleep disorder.As corrective treatment the patient received clonazepam.The patient did not recover from event.In initial of (b)(6) 2015, reported as two week ago from initial report, the humapen luxura champagne had unspecified problems and was broken(as reported).It was reported that the needle was reused, changing once a week, the patient received the human insulin only in abdomen.Due to problem with humapen luxura champagne, the operator took the humapen (unknown device) which the patient delivered human insulin regular, and replaced the current cartridge to deliver human insulin 30%regular +70%nph.But the operator did not perform prime, and the injection screw did not touch the cartridge plunger, and as consequence, the patient did not receive the dose of human insulin 30%regular +70%nph via this humapen(unknown device).The patient did not receive corrective treatment, but he recovered from event.On "(b)(6) 2016", the humapen luxura champagne was returned and found to have a barrel misalignment.This device was not associated with an adverse event.The human insulin nph, human insulin 30%regular +70%nph and human insulin regular were continued.The consumer is the operator of device, and she is a trained user.It was unknown how long the device models were used, and it was unknown how long the reported device was used.The status of the device associated with (b)(4) was not provided.The device associated with (b)(4) was returned on 26-nov-2015.The reporting consumers did not provide opinion of relatedness.14dec2015: additional information received on 04dec2015 from the second reporter consumer.No medically significant information was provided.Update 22-dec-2015: additional information received on 22-dec-2015 from the global product complaint database added the return date of the device of 26-nov-2015 associated with (b)(4); updated this device to suspect; updated the malfunction field to yes/cirm; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.Edit 23dec2015: upon review on information of 16nov2015.Amended minor information related to device on case narrative; update 29jan2016: additional information received on 29jan2016 from the global product complaint database added the device specific safety summary and manufactured date for the humapen luxura champagne associated with the (b)(4); updated the improper use and storage to yes; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.

• Brand Name: HUMAPEN LUXURA, CHAMPAGNE
• 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: 5323637
• MDR Text Key: 35013594
• Report Number: 1819470-2015-00122
• 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: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9663
• Device Lot Number: 1202B05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2015
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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