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

Model Number MS9557

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infarction, Cerebral (1771); High Blood Pressure/ Hypertension (1908); Hypoglycemia (1912)

Event Date 01/31/2014

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), concerned a (b)(6) female patient.Medical history included cerebral infarction and hypertension.Concomitant medications were not provided.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) (humulin 70/30) via reusable pen (humapen unknown and humapen ergo ii), 19 each morning and 9 at night (units were not provided), subcutaneously, for the treatment of diabetes mellitus beginning in 2008.Humapen unknown type was used from 2008 to 2013.On an unreported dated the humapen unknown type had an unknown problem (product complaint pending/lot unknown), and she began using a humapen ergo ii in 2013.Sometime after receiving human insulin 70/30, she experienced hypoglycemia at night and had some food.She also noticed her eyes were not good after taking insulin.On an unreported date, the humapen ergo ii began having an unspecified problem (product complaint pending/lot 0801d07).In 2014, she developed hypoglycemia and had cavity obstruction caused by insufficient blood supply and was hospitalized physician changed human insulin 70/30 treatment dose to 19 each morning only and then her fasting blood glucose (fbg) was 6 (units were not provided) and postprandial blood glucose (pbg) 2 hours after meal, was 12-13 (units were not provided).Information regarding corrective treatment, hospitalization details and outcome of the events was not provided.Human insulin 70/30 treatment was ongoing.The user of the humapen and humapen ergo ii and his/her training status was not provided.The humapen unknown model duration of use was from 2008 to 2013.The humapen ergo ii model duration of use was not provided but started in 2013.The status of the humapen or humapen ergo ii was not provided.The reporting consumer did not know if the events were related to human insulin 70/30 or humapen ergo ii and humapen unknown type.Update 14jun2016: upon review, the case was opened to complete the medwatch and update the european and canadian required device reporting elements for regulatory reporting; update the status of the devices in the narrative; and add the product complaint descriptions to the narrative.

Manufacturer Narrative

Narrative field - new, updated and corrected information is referenced within the update statements in describe event or problem no further follow up is planned.Evaluation summary a female patient reported a large gap between the dose knob and the body of her humapen ergo ii device.She experienced hypoglycemia.The device was not returned to the manufacturer for investigation (batch (b)(4), manufactured january 2008).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of the batch did not identify any atypical trends with regard to device broken or dose accuracy.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring dose accuracy and device functionality with a high probability.There is no evidence of improper use or storage.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter, in response to a follow-up questionnaire, concerned a (b)(6) female patient.Medical history included cerebral infarction and hypertension.Concomitant medications were not provided.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) (humulin 70/30) via reusable pen (humapen unknown and humapen ergo ii), 19 each morning and 9 at night (units were not provided), subcutaneously, for the treatment of diabetes mellitus beginning in 2008.Humapen unknown type was used from 2008 to 2013.On an unreported dated the humapen unknown type had an unknown problem ((b)(4)/lot unknown), and she began using a humapen ergo ii in 2013.Sometime after receiving human insulin 70/30, she experienced hypoglycemia at night and had some food.She also noticed her eyes were not good after taking insulin.On an unreported date, the humapen ergo ii began having an unspecified problem ((b)(4)/lot 0801d07).In 2014, she developed hypoglycemia and had brain cavity obstruction caused by brain insufficient blood supply and then was hospitalized physician changed human insulin 70/30 treatment dose to 19 each morning only and then her fasting blood glucose (fbg) was 6 (units were not provided) and postprandial blood glucose (pbg) 2 hours after meal, was 12-13 (units were not provided).By (b)(6) 2016, she was recovering from the events of cavity obstruction and insufficient blood supply, and the outcome of the remaining events was unknown.Information regarding corrective treatment and hospitalization details, were not provided.Human insulin 70/30 treatment was ongoing.The user of the humapen and humapen ergo ii and his/her training status was not provided.The humapen unknown model duration of use was from 2008 to 2013.The humapen ergo ii model duration of use was not provided but started in 2013.The status of the humapen or humapen ergo ii was not provided.The reporting consumer did not know if the events were related to human insulin 70/30 or humapen ergo ii and humapen unknown type.Update 14jun2016: upon review, the case was opened to complete the medwatch and update the european and canadian required device reporting elements for regulatory reporting; update the status of the devices in the narrative; and add the product complaint descriptions to the narrative.Update 30-jun-2016: additional information was received from the initial reporter on 28-jun-2016, in response to a follow-up questionnaire.Updated the outcome of the serious adverse events of obstruction and ischemia from unknown to recovering and the event of ischemia was updated to cerebral ischemia, since was confirmed the localization.The as reported terms of the serious event cavity obstruction was updated to include brain cavity obstruction, also the as reported terms of the serious event of insufficient blood supply was updated to include brain insufficient blood supply.Updated the narrative with new information.Update 08jul2016.Additional information received 07jul2016 from the product complaint safety database.To the second device tab added manufacture date, approximate device age, entered the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, updated the device medwatch information, and the narrative was updated accordingly.Update 18-jul-2016: pc numbers were received from the affiliate on 12-jul-2016, but they were already processed, second pc number was added in narrative.

• 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: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 5725581
• MDR Text Key: 47456683
• Report Number: 1819470-2016-00144
• 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,Followup
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 0807D07
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2008
• Is the Device Single Use?: Yes
• 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: 68 YR
• Patient Weight: 60