MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES

Model Number MS9557

Device Problem Inadequate User Interface (2958)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Thrombosis (2100); Convulsion, Clonic (2222); Shaking/Tremors (2515); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Description of problem or event: new, updated and corrected information is referenced within the update statements.Please refer to update statement(s) dated 26jul2019.No further follow-up is planned.Evaluation summary: a male patient reported that his humapen ergo ii device was cracked at the site of the injection button, the dose window and soft touch were detached, and the injection button would not push down when it showed one to two units were left.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (0712d04, manufactured december 2007).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review did not identify any atypical findings with regard to dose accuracy, pen jam, or device not working.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.While it is unknown how long the patient used the device, based on the amount of time elapsed since the device was manufactured (december 2007), it is likely the patient used it beyond its approved use life.The user manual states the humapen ergo ii has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient likely used the device beyond its approved use life.It is unknown if this is relevant to the event of increased blood glucose.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via a psp (patient support program), with additional information from a second reporting consumer, concerned a (b)(6) years old (b)(6) male patient.Medical history included family diabetes history.Concomitant medication included metformin and acarbose for the treatment of diabetes mellitus.He also received insulin human isophane injection (novolin 50) and insulin aspart for unknown indication.The patient received insulin human (humulin70/30) cartridge via reusable pen (humapen ergo 2), 20 units each morning and 18 units each night, subcutaneously for the treatment of diabetes mellitus, beginning in 1999.In 2006, while using humulin70/30, the patient was hospitalized due to cerebral thrombosis.Before discharge, the patient had an allergy test done and he was trembling all over.The patient was going to have a radiography, but the doctor indicated the patient could not do radiography due to trembling.Afterwards, back at home there was a sequela of leg convulsion.Events of cerebral thrombosis and leg convulsion were considered serious due to medical significance.In 2008, there was a second cerebral thrombosis; as a sequela, his hands curved inside and walking was not good.In 2010, the patient ate cake without sugar alcohol for celebrating his birthday, and 2 or 3 days after that, he was sleepy, severe thirsty and blood glucose was too high to test (no values or units provided).Around 2016-2017, the patient began using (novolin50), due to the novolin50 insulin could have meals just after injection finish.The blood glucose was very high (no units provided).The patient also used insulin aspart and also there was high blood glucose and hospitalization.Further details regarding hospitalization were not provided.Patient discontinued humulin 70/30 on unknown date for unknown reason and he restarted to take it around the end of 2017 to 2018.In (b)(6) 2019, a humapen had the condition that the rubber soft cushions came off, due to this, the patient omitted dose ((b)(4) / lot 0712d04).On unknown date, he stored an unopened insulin in 10-20 centigrade, over the regulations.Since unknown date, the blood glucose was sometimes high (fasting blood glucose:8,11,12,postprandial blood glucose:12,13,15,16).There was sometimes hypoglycemia and palpitation (blood glucose:around 3,4,5).Outcome for dose omission and storage error was unknown.Outcome for the remaining events was not recovered.As of (b)(6) 2019, the patient was still on humulin 70/30.Follow up would not be possible with reporter and healthcare professional as the reporter refused to be followed up and had no physician contact information.The user of the humapen ergo ii was the patient and his training status was not provided.The humapen model duration of use and the suspect humapen duration of use was not provided.The suspect device, which was manufactured in dec2007, was not returned to the manufacturer.The first reporting consumer did not know if the event of dose omission was related to humulin 70/30 or the humapen ergo ii.The second reporting consumer assessed the events as not related to humulin 70/30, and did not provide an opinion for humapen ergo ii.Update 29-mar-2019: this case was determined to be non-valid as there was no identifiable adverse event.Update 03-apr-2019: information was received on 01-apr-2019 which contained the product complaint (pc) number (b)(4).Pc was already processed.No other changes were made to the case and no new clinically or medically significant information was added in the case.Update 18-jul-2019: additional information received on (b)(6) 2019 from a second reporting consumer via psp.This case was upgraded to serious due to the addition of the serious events of cerebral thrombosis (two events), convulsions local and blood glucose increased.Also added the non serious events of tremor, hand deformity, gait disturbance, somnolence, blood glucose increased (two events), thirst, product storage error and hypoglycemia.Added patients height, weight, origin, age, medical history and concomitant medications.Also added restart date for humulin 70/30 treatment and eu/ca fields for humapen ergo.Narrative and fields were updated accordingly, edit 23jul2019: updated medwatch fields for expedited device reporting.No new information added.Update 26jul2019: additional information received on (b)(4) 2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and (b)(4) (eu/(b)(4)) device information, improper use and storage from no to yes, and device return status to not returned to manufacturer.Added date of manufacturer for (b)(4) associated with lot 0712d04 of a humapen ergo ii device.Corresponding fields and narrative updated accordingly.Update 06aug2019: additional information received on (b)(4) 2019 from the global product complaint database.No new information was added.

• Brand Name: HUMAPEN ERGO II
• 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; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 8875730
• MDR Text Key: 154099840
• Report Number: 1819470-2019-00139
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 08/08/2019

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 0712D04
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2007
• 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
• Patient Age: 70 YR
• Patient Weight: 72