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); Difficult or Delayed Activation (2577)

Patient Problems Breast Cancer (1759); Dementia (1808); Hyperglycemia (1905); Hypoglycemia (1912); Incontinence (1928); Memory Loss/Impairment (1958); Malaise (2359)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

New updated and corrected information is referenced within the update statements in describe event or problem.No further follow up is planned.Evaluation summary: the daughter of a patient reported the button of the humapen luxura device "goes down directly" when pressed.The daughter also indicated the needle was clogged, and "insulin would never be released due to the clogging problem in the needle." the patient experienced increased blood glucose.The device was not returned for investigation (batch 1210b02, manufactured october 2012).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the batch did not identify any atypical findings with regard to device not working.All humapen luxura devices are assessed for injection screw travel and backdrive force at the end of the manufacturing process, thus ensuring device functionality with high probability.It was reported the patient reused needles and stored the device with the needle attached.The instructions for use state, "use a new needle for each injection," and "remove the needle after every use.Do not store the pen with the needle attached." there is evidence of improper use and storage.The patient reused needles and stored the device with a needle attached.It is unknown if these are relevant to the event of increased blood glucose.

Event Description

(b)(4).This solicited case reported by a consumer, regarding a patient who took part of a patient support program (psp), concerns an elderly (b)(6) female patient; was born on (b)(6).Medical history included fall; femur prosthesis; walker user; head injury and head trauma due to a running over in 1992 (conflicting information also reported as 2004) and as sequel of this, patient could remember from past but she had difficult to remember present and it was talk about dementia; audition problem before 2006.Concomitant medications included amlodipine, losartan potassium, hydrochlorothiazide, metformin, omeprazole, donepezil hydrochloride, sertraline hydrochloride and metamizole sodium, all for unknown indication.The patient received human insulin (rdna origin) nph (humulin n) cartridge, 18 iu in the morning and 10 iu in the evening, subcutaneously, for high diabetes and glycated hemoglobin problem, beginning in 2012 or 2013.On an unspecified date, unknown time after commencing human insulin nph treatment, patient experienced beginning of alzheimer, which was considered serious by the company due to medically significant reasons.No further information provided.Patient did not received corrective treatment and outcome was not provided.On an unknown date in 2014, patient discovered a breast cancer, which was considered serious by the company due to medically significant reasons.As corrective treatment, patient received an unspecified medication reported as eletrosol and patient recovered on an unknown date (also reported as the cancer decreased).Approximately on (b)(6) 2016, unknown exact time after commencing treatment with human insulin nph via humapen luxura champagne (lot 1210b02), patient experienced episodes of hypoglycemia.As corrective treatment, patient ate cookie or bread.Due to this event, patients physician decreased the evening dose to 8iu but hypoglycemia continued.Therefore, on (b)(6) 2016, physician changed the dosage of human insulin nph for 22 iu in the morning and 4 iu in the evening and hypoglycemia still continued.On a non-reported date, the nocturnal dose of human insulin nph was suspended.Since (b)(6) 2016, the injection button of humapen luxura champagne (lot 1210b02) was rigid, sometimes it was hard and sometimes not; some days when patient was alone and the injection button was hard, she did not take what she needed ((b)(4)).Information regarding corrective treatment and outcome of possible underdose was unknown.Patient always reused the needles and stored the device with needle attached.On (b)(6) 2016 (conflicting information also provided as (b)(6) 2016), hypoglycemia stopped and patients diabetes was getting very high.On (b)(6) 2016, diabetes was 300 (units and normal range not provided) and on (b)(6) 2016 it was 185, sometimes it was 180, 187.In addition, it was stated that patients feeding remained the same.As corrective treatment, patient received the medication (as reported) or went to emergency room.As of (b)(6) 2016, patient was not recovered from high diabetes.In (b)(6) 2017, approximately four or five years after starting the treatment with human insulin nph, patient s previous breast cancer returned.The new event of breast cancer was considered serious due to medically significant reasons by the company.No information of laboratorial exams and corrective treatment were provided; the patient was not recovered from breast cancer.Also in (b)(6) 2017, since the nocturnal dose of human insulin nph was suspended, in the morning patient woke up with glycaemia around 300, 400 and 500 (units not provided).During a consult on (b)(6) 2017, patient s daughter complained that the patient s glycaemia did not decrease and that it was a good thing that the patient was in use of metformin.No information of corrective treatment and outcome were provided.On an undisclosed date, humapen luxura champagne presented an issue again; the injection button went straight down after being pressed.On an unknown date of (b)(6) 2017, patient did not receive human insulin nph for a week due to device problem and to a clogged needle ((b)(4)/ lot 1210b02).During the weekend of (b)(6) 2017, patient's diabetes was very high; it reached 600 and 680 (units not provided).The patient began urinating around the whole house and for this reason her underwear had to be changed 10 times.On an unknown date, patient was hospitalized and received insulin regular (unknown manufacturer) and physiological saline solution.Once the solution was at its half volume and her glycaemia went down, she felt unwell; according to the physician, her body was so used to a high glycaemia that she felt unwell when it lowered.It was stated that the patient did not feel anything when the glycaemia was high, she only started to drink a lot of water and had to be rushed to the hospital.The date of patient s discharge from the hospital was not provided.As of (b)(6) 2017, patient s glycaemia was 140 (units not provided) and she would be taken to the emergency room.Additionally, it was provided that one of the biggest problems of the patient was her glycated hemoglobin, which was increasing.No further information of corrective treatment was provided; the patient was not recovered from blood sugar increased and glycated hemoglobin increased, and the outcome for feeling unwell, drug dose omission, blood glucose decreased and urinary incontinence was not provided.Human insulin nph treatment continued.Patient was the operator of device and she was trained.The device model had been used for five or six years.The same humapen luxura (lot number 1210b02) was associated with both product complaints (b)(4) (reported in 2016) and (b)(4) (reported in 2017).The return status of the suspect humapen luxura was not provided.Reporting consumer did not known if hypoglycemia and blood glucose increased were related to human insulin nph treatment and did not relate alzheimer to human insulin nph.The reporting consumer related the return of breast cancer to patient s high glycaemia and to the device; the event of high glycaemia (that led to hospitalization) was not related to human insulin nph and it was related to the device.No opinion of relatedness was provided for the remaining events.Update 07nov2017: additional information received from initial reporting consumer on 06nov2017.Added a new tab of dosage regimen for the morning dose only.Added information that the nocturnal dose of human insulin nph was suspended.Added a new suspect device tab for the same pen humapen luxura champagne lot number 1210b02.Added insulin regular and physiological saline solution as treatment drugs.Added serious events of breast cancer and blood sugar increased; added non-serious events of blood sugar increased (episode that did not lead to hospitalization), drug dose omission, feeling unwell, glycosylated hemoglobin increased, blood glucose decreased and urinary incontinence.Added glycaemia values of 300, 400, 500, 600, 680 and lastly 140 as lab data.Updated time of use of humapen luxura champagne to five to six years; added information that it was unknown if the second product complaint was resolved, if the use of the device was continued and if it would be returned to the manufacturer.Updated causality paragraph.Narrative and corresponding fields were updated accordingly.Update 21nov2017: additional information received on 21nov2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information.Added date of manufacturer.Corresponding fields and narrative updated accordingly.Edit 30nov2017: upon internal review on (b)(6) 2017, corrected coding of second event of breast cancer to malignant neoplasm progression.Corrected relatedness of suspect devices: for the humapen luxura champagne that was coded first in 2016, the causality was only entered for the events of alzheimer s disease, breast cancer, blood glucose increased (non-serious), underdose and hypoglycemia; for the same humapen luxura champagne that was coded in 2017, the causality was only entered for the events of malignant neoplasm progression, blood sugar increased (serious and non-serious),glycosylated hemoglobin increased, urinary incontinence, blood glucose decreased, malaise and drug dose omission (all entered in 2017).Also, corrected the fourth paragraph to make it clearer that there was only one suspect device in this case (humapen luxura champagne) associated with two product complaints.

• 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: 7083607
• MDR Text Key: 93757403
• Report Number: 1819470-2017-00207
• 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
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9663
• Device Lot Number: 1210B02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2012
• 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): Hospitalization; Other
• Patient Age: 85 YR
• Patient Weight: 60